A COMPARATIVE, PROSPECTIVE STUDY OF EFFECT OF 10

DEGREE REVERSE TRENDELENBERG POSITION ON BLOCK

CHARACTERISTICS AND HAEMODYNAMIC PARAMETERS IN
UNILATERAL SPINAL ANAESTHESIA IN KNEE AND BELOW
KNEE ORTHOPAEDIC SURGERY

THESIS

SUBMITTED TO HIMACHAL PRADESH UNIVERSITY, SHIMLA

IN PARTIAL FULFILLMENT OF THE REQUIREMENT
FOR THE DEGREE OF

DOCTOR OF MEDICINE
ANAESTHESIOLOGY

2016 - 2019

SUBMITTED BY:
DR. MANUJ KUMAR
POSTGRADUATE STUDENT
DEPARTMENT OF ANAESTHESIOLOGY
DR. RAJENDRA PRASAD GOVT. MEDICAL COLLEGE
KANGRA AT TANDA (H.P.)
 CERTIFICATE

We certify that work and techniques mentioned in this thesis for MD Anaesthesiology
entitled “A comparative, prospective study of effect of 10 degree reverse
trendelenberg position on block characteristics and haemodynamic parameters in
unilateral spinal anaesthesia in knee and below knee orthopaedic surgery” by
Dr. Manuj Kumar has been undertaken by candidate himself under our guidance and
supervision in the Department of Anaesthesiology of Dr. Rajendra Prasad Govt.
Medical College, Kangra at Tanda. We guided the candidate in his work and saw that
the data being included in the thesis was genuine and the work was done by the
candidate himself.

GUIDE

Dr. RAVINDER KUMAR VERMA

Professor
Department Of Anaesthesiology
Dr. Rajendra Prasad Government Medical College
Kangra at Tanda, (H.P.)

CO-GUIDES

Dr. BHANU AWASTHI Dr. SHYAM BHANDARI

Professor and Head Assistant Professor
Department of Orthopaedics Department of Anaesthesiology
Dr. RPGMC Kangra at Tanda, (H.P.) Dr. RPGMC Kangra at Tanda,(H.P.)
 ACKNOWLEDGEMENT

Firstly, I would like to thank almighty God, without his blessings no

endeavour can start, continue or complete.

It is a proud privilege for me to express my gratitude and indebtedness to

my teacher and guide Professor Ravinder Kumar Verma, Department of

Anaesthesiology, who inspired me to take up this study. His vast

knowledge, experience, constant encouragement, keen interest, invaluable

guidance enabled me to complete this work successfully.

I am extremely thankful to my teacher and co-guide Professor Bhanu

Awasthi, Professor and Head, Department of Orthopaedics, for his

experienced guidance from time to time in shaping this thesis.

I am extremely grateful to my teacher and co-guide Dr. Shyam Bhandari,

Assistant Professor, Department of Anaesthesiology, for his experienced

guidance, keen interest and personal care in planning and executing this

work.

I am also thankful to Professor Sudershan Kumar, Professor and Head,

Department of Anaesthesiology, for his support, keen interest and constant

encouragement, enabling me to complete this work.

I am also grateful to Professor Jai Singh, Professor Shelly Rana,

Dr. Bharti Gupta, Dr. Versha Verma, Dr. Dheeraj Singha, Dr. Usha

Chaudhary and Dr. Shalini Sharma for their valuable suggestions,

support and guidance. My heartfelt thanks to all senior residents, junior

residents and staff of the department along with all the patients who took

part in this study.

I am also thankful to my family and friends without whose constant

encouragement all this could not be done.

MANUJ KUMAR
 ABBREVIATIONS

ASA American Society of Anaesthesiologists

B.P. Blood Pressure

BMI Basal Metabolic index

CSE Combined Spinal Epidural

CSEA Combined Spinal Epidural Anaesthesia

CSF CerebroSpinal Fluid

CVS Cardiovascular system

CXR Chest X-ray

CSA Continuous Spinal Anaesthesia

DBP Diastolic Blood Pressure

Deptt. Department

D Dependent

Dr. RPGMC Dr. Rajendra Prasad Government MedicalCollege

ECG Electro Cardio Graphy

GPE General Physical Examination

Hb Haemoglobin

H.P. Himachal Pradesh

HR Heart Rate

Hrs Hours

HU Head up
ICMR Indian Council of Medical Research

MAP Mean Arterial Pressure

Min Minute

mg milligram

mm of Hg millimetre of mercury

MS Excel Microsoft Excel

ND Nondependent

NIBP Non Invasive Blood Pressure

PDPH Post Dural Puncture Headache

Pubmed Medical Publication

RFT Renal Function Tests

RR Respiratory Rate

SBP Systolic Blood Pressure

SD Standard Deviation

sec Seconds

S Supine

Spo2 Oxyhaemoglobin Saturation

SA Spinal Anaesthesia

USpA Unilateral Spinal Anaesthesia

 CONTENTS

SI.NO. PARTICULARS PAGE NO.

1. INTRODUCTION 1-4

2. REVIEW OF LITERATURE 5-11

3. PHARMACOLOGY 12-16

4. AIM & OBJECTIVES 17

5. MATERIAL AND METHODS 18-24

6. STASTICAL ANALYSIS 25

7. OBSERVATION AND RESULTS 26-42

8. DISCUSSION 43-49

9. SUMMARY 50-52

10. CONCLUSION 53

11. BIBLIOGRAPHY 54-59

12. ANNEXURES
 Introduction

INTRODUCTION

Spinal anaesthesia has enjoyed a long history of success and has been in use for

mankind for more than a century now.1 Spinal anaesthesia involves the use of small

amounts of local anaesthetic injected into the subarachnoid space to produce a reversible

loss of sensation and motor function. The easy and long history of spinal anaesthesia may

give the impression that it is a simple technique but this is not true.

The injection of local anaesthetic in the subarachnoid space can result in

haemodynamic and respiratory changes. If it was possible to limit anaesthesia for the

surgical field, certain undesirable effects of spinal anaesthesia could be avoided.

Spinal anaesthesia is often used for orthopaedic surgery especially in lower limb

surgeries.2 However, because of the high prevalence of hypotension and bradycardia risk

is always there especially in elderly age group because of their compromised

haemodynamic status.3-5

Localized spinal analgesia in surgery was described as early as 1909 by

Jonnesco.6 Since that time various techniques have evolved, each attempting to confine

the extent of somatic and sympathetic paralysis to the site of operation.7 Among such

techniques are segmental spinals,8 in which localization is effected by placing catheters to

predetermined levels in the subarachnoid space and “unilateral” spinals9 in which

limitation of spread is accomplished by using hyperbaric or hypobaric solutions.

The term unilateral spinal anaesthesia is used when block is of operative side only

with absence of block on non-operative side.10 When surgery involves only one lower

limb, such block is advantageous as it minimizes cardiovascular effects, avoids motor

block of non-operative limb and facilitates early discharge.11,12 Although unilateral spinal

1
 Introduction

is often practiced, but the potential to control the speed of drug, there by restricting the

distribution of spinal block to the operative side, remains controversial and frequently

debated.13,14 Low dose local anaesthetic solutions by using a pencil-point needle and slow

intrathecal injection have been reported to obtain satisfactory unilateral spinal anaesthesia

(USpA).15 USpA techniques allow the administration of small doses of local anaesthetic

and thus provide a more controllable sensory and sympathetic level of anaesthesia.

Finally, USpA has more stable cardiovascular parameters compared with conventional

bilateral spinal block.16

USpA aims to limit the distribution of spinal block to the operated side, because

most of the operative procedures involve only one lower limb.17 Compared with the

conventional technique, it requires a bit longer preparation time to get the drug fixed to

the side to be operated in preference to non-operating limb. It produces fewer

haemodynamic side-effects and has higher cardiovascular stability, increased autonomy

after surgery and better patient acceptance.17,18 It also reduces the incidence of clinically

relevant hypotension following spinal anaesthesia. Hypotension is the most frequent side

effect of spinal anaesthesia, occurring in more than 30% of patients.3

Spinal anaesthesia typically cause decrease in arterial blood pressure with only

minor decrease in heart rate, stroke volume, or cardiac output even with poor left

ventricular function. In conventional spinal anaesthesia, it is not possible to limit the

accompanied sympathetic block that normally exceeds the sensory block by 2-6

segments.19,20

Hypotension occurs from decrease in systemic vascular resistance from

sympathetic block with vasodilation and redistribution of central blood volume to lower

2
 Introduction

extremities and splanchnic beds. Various prophylactic and rescue regimens have been

advocated for haemodynamic disturbances with emphasis on prevention of hypotension.

A potential way for prophylaxis of hypotension is by manipulation of spinal

anaesthesia to achieve a predominantly unilateral block.17 The unilateral spinal

anaesthesia has been claimed by many as an alternative technique, to restrict the

undesired sympathetic block.21 Unilaterality can be maintained if patient remains in a

lateral position for surgery; however, eventual turning of the patient into a supine position

results in partial redistribution to bilateral anaesthesia. Thus patient’s position during and

immediately after spinal anaesthesia influences the spinal distribution of drug i.e. patient

position is fundamental basis for unilateral block.22 It also results in rapid recovery and

greater satisfaction among outpatients, in addition to preventing unnecessary nerve block

in the contralateral limb.23, 24

One of the major issues in orthopaedic surgery is requirement of lateral position

for many surgeries like total hip replacement, bipolar hip arthroplasty etc. Lateral position

can lead to uneven distribution of spinal anaesthesia in both lower limbs.

While clinicians describing this unilateral technique allude to an associated

decrease in anaesthetic morbidity, not many controlled clinical studies have been reported

comparing this technique to conventional bilateral spinals. In some studies reported

earlier the true “unilaterality” of the sympathetic blockade was termed dubious.10 Some

clinicians have expressed doubt that such unilateral sympathetic paralysis can be

obtained, and they feel, therefore, that the rationale behind the unilateral spinal is

fallacious. Extensive pubmed search did not reveal any study regarding the effect of 10

degree reverse trendelenberg position on unilateral spinal anaesthesia. Thus this study

was undertaken to evaluate the effects of 10 degree reverse trendelenberg position in

3
 Introduction

unilateral spinal anaesthesia comparing it with a control group in supine position for

block characteristics and haemodynamic parameters.

Also this study was aimed at providing answers to question that is it possible to

restrict spinal anaesthesia to one specific side so that the loss of sensory, motor, and

sympathetic function is confined to just one side of the body, i.e., a true hemispinal? We

also tried to look into the fact that does the use of reverse trendelenberg decrease the

incidence of the commonest complication of spinals, namely hypotension; and is this

technique clinically advantageous?

4
 Review of Literature

REVIEW OF LITERATURE

In practice, a conventional unilateral spinal anaesthesia technique can only result

in a motor hemiblock and a sensory block preferential to one side but achieving

unilaterality is not an easy task as numerous factors come into play. Some of these factors

include type of needle and its bevel direction, speed of injection, volume of drug, baricity,

concentration of local anaesthetic and position of patient on operating table. Of all the

above factors, patient position is most vital in determining effects of spinal anaesthesia on

one major side i.e. the side which is to be operated.23 Several studies have shown the

usefulness of unilateral block in ASA I and II patients. 24,25

Kuusniemi et al.26 conducted a study to evaluate the effect of volume,

concentration and total dose of local anaesthetic on the spread of spinal anaesthesia,

comparing low-dose Bupivacaine (6 mg) in 0.5% and 0.18% solutions to achieve

predominantly unilateral spinal anaesthesia for knee arthroscopy in sixty patients divided

into two groups who received either 1.2 mL 0.5% Bupivacaine (6 mg) or 3.4 mL 0.18%

Hypobaric Bupivacaine (6.1 mg) in the lateral position for 20 min before turning supine

for the operation. They concluded that there were no significant changes in the duration

of sensory or motor block, haemodynamic profile, degree of motor block and duration of

spinal anaesthesia with Bupivacaine (6 mg) in low (1.2 mL) or high (3.4 mL) volume.

Chohan et al.27 conducted a study in 40 ASA 3 and 4 patients of age 60-90 to

assess if a unilateral spinal anaesthesia with 0.5% Hyperbaric Bupivacaine (1-1.8mL)

restricts the sympathetic block preventing the undesired cardiovascular effects, by placing

them in the lateral position for 10 min after spinal anaesthesia, monitoring block levels

and haemodynamic alterations for 30 min. They concluded that unilateral spinal

5
 Review of Literature

anaesthesia is effective in restricting the sympathetic block in high risk patients with

better haemodynamic profile intra operatively.

Nair et al.28 conducted a study about the recovery profile of patients undergoing

spinal anaesthesia, using Bupivacaine for arthroscopic knee surgery, comparing different

doses of Bupivacaine (range 3–15 mg) in 5 clinical trial which showed that large doses

(10 and 15 mg) caused delayed recovery while supine positioning produced high failure

rates and that 4–5 mg of Hyperbaric Bupivacaine can effectively produce spinal

anaesthesia for knee arthroscopy with unilateral positioning.

Atef et al.29 conducted a prospective, randomized, clinical study in 80 patients in

four groups to receive intrathecal Hyperbaric Bupivacaine 5 mg (1), 7.5 mg (2), 10 mg (3)

and 12.5 mg (4) respectively, finding unilateral sensory block in 90% and 85% in Group

1 and 2 respectively, but not in group 3 and 4. Unilateral motor block (modified bromage

scale 0) was reported in 95%, 90%, 5%, 0% in Group1, 2, 3 and 4 respectively. Hence

they concluded that 7.5 mg of Hyperbaric Bupivacaine 0.5% was effective for adequate

unilateral spinal anaesthesia.

Akhtar et al.30 conducted a study to assess the haemodynamic changes in 60

patients receiving unilateral and bilateral spinal anaesthesia using 1.5 mL of 0.75%

Hyperbaric Bupivacaine, randomly allocated in two groups of 30 patients each as supine

or lateral decubitus position respectively and kept so for 10 min as per group. They

concluded that unilateral spinal anaesthesia was associated with a more stable

cardiovascular profile.

Kilinc et al.31 conducted a study to compare the effects of continuous spinal

anaesthesia (CSA) and unilateral spinal anaesthesia (USpA) techniques on

haemodynamic parameters, quality of anaesthesia and complications in 40 elderly

6
 Review of Literature

patients aged more than 65 years, undergoing hip surgeries, assigned to receive either

CSA or USpA with 7.5 mg (1.5 cc) 0.5% Hyperbaric Bupivacaine initially. They found

that haemodynamic parameters, Ephedrine requirements and regression of sensory block

by two levels were similar in two groups. Finally they concluded that both techniques

have similar effects in elderly high risk patients but USpA is preferable for short surgeries

due to its low cost and high success rate.

Moosavi Tekye et al.32 conducted a prospective randomized study to compare

unilateral and bilateral spinal anaesthesia with respect to its intra and postoperative

advantages and disadvantages. Spinal anaesthesia was induced with 0.5% Hyperbaric

Bupivacaine in two groups, in sitting and lateral position respectively, using 2.5 cc and

1.5 cc of Hyperbaric Bupivacaine. Patients were kept in the lateral decubitus position for

20 min. They found that the time of onset of the sensory and motor block was shorter in

group A while duration was shorter in group B. The success rate for unilateral spinal

anaesthesia in group B was 94.45%. They concluded that when unilateral spinal

anaesthesia is performed using a low-dose, low-volume and low-flow injection technique,

it provides adequate sensory-motor block, stable haemodynamic parameters during lower

limb surgeries, more patient satisfaction and avoids unnecessary paralysis on the non-

operative side.

Singh TK et al.33 conducted a study in 120 patients aimed to determine the

incidence and suitability of unilateral spinal block, hypotension and recovery profile

using 7.5 mg of 0.5% Hyperbaric Bupivacaine alone or with fentanyl/clonidine for knee

or below knee orthopaedic surgery of moderate duration, who received 7.5 mg of 0.5%

Hyperbaric Bupivacaine intrathecally with 25 μg of fentanyl (Group BF), 25μg of

clonidine (Group BC) or 0.5 mL of saline (Group BS). Block characteristics, unilaterality,

7
 Review of Literature

haemodynamic changes and recovery profile were noted. They found that unilateral block

was seen in more than 70% of patients in all the groups. Time of regression of sensory

block to L2 level (133 ± 18, 187 ± 19, 182 ± 18 min respectively in groups BS, BF and

BC) was prolonged in groups BF and BC. Motor block was prolonged in group BC only.

So, they concluded that 7.5 mg of Hyperbaric Bupivacaine alone or with fentanyl or

clonidine produced predominantly unilateral spinal anaesthesia in more than 70% patients

in the entire group with stable cardiovascular parameters. Addition of fentanyl or

clonidine did not influence unilaterality or block characteristics but prolonged

postoperative analgesia.

Lee et al.34 aimed to determine whether head elevation during combined spinal-

epidural anaesthesia (CSE) in caesarean section provided improved haemodynamics and

appropriate sensory block height, in 44 parous women who were randomly assigned to

two groups: right lateral (group L) and head elevated (group HE) position, positioning

them in the supine wedged position (group L) or the left lateral and head elevated position

(group HE) until a block height of T5 was reached. Then HE group was turned supine

wedge with head elevation until end of surgery. They concluded that head elevation is

superior, producing a more gradual onset, appropriate block height, and improved

haemodynamics.

Fall et al.35 conducted a study in 70 patients of age more than 70 years randomized

into 2 groups, to see the differences between unilateral spinal anaesthesia (USA) and

conventional spinal anaesthesia (SA) in terms of haemodynamic consequences in

traumatic hip surgery. Spinal anaesthesia was performed with 7.5 mg of Bupivacaine

0.5% Hypobaric and fentanyl 25 μg. Patients were kept in lateral decubitus for 15 min

8
 Review of Literature

(USA) and immediately turned supine (SA). They found that haemodynamic

consequences were significantly lower in the USA group.

Jyoti Sandeep Magar et al.36 in a prospective randomized study on sixty ASA I-III

patients aged 18- 65 years undergoing lower limb orthopaedic surgeries of approximately

two hours duration divided into 2 groups with sequential CSE group receiving spinal with

5 mg of 0.5% Hyperbaric Bupivacaine followed by incremental epidural top up of 2 cc of

0.5% isobaric Bupivacaine and unilateral SA group receiving unilateral spinal anaesthesia

with 10 mg of 0.5% Hyperbaric Bupivacaine while assessing haemodynamic parameter

and block characteristics found that surgical anaesthesia with T10 sensory level and

bromage score three motor block was achieved by all patients in both groups. Incidence

of hypotension (P-value 0.0059) and mean Ephedrine dose were significantly less in

sequential CSEA, thus, concluding that unilateral SA is a cost-effective and rapidly

performed anaesthetic technique. Unilateral SA with 10 mg Bupivacaine and sequential

CSEA with 5 mg spinal and incremental epidural top up, both provide good quality

sensory and motor block for lower limb orthopaedic surgery.

Liaquat Ali et al.37 in a study to determine the safety of unilateral spinal

anaesthesia in 20 (ASA) III and IV elderly patients with cardiac failure undergoing major

unilateral lower limb orthopaedic surgery using 0.75% Hyperbaric Bupivacaine 7.5 mL,

keeping them in lateral position for 10 min. Haemodynamic variations were monitored

and recorded. The block remained unilateral in all cases thus concluding that unilateral

subarachnoid block with Hyperbaric Bupivacaine does not produce adverse

haemodynamic changes and under controlled setting and meticulous monitoring elderly

patients with variable degree of heart failure can be safely given unilateral spinal

anaesthesia for major lower limb orthopaedic surgery.

9
 Review of Literature

Alieh Zamani Kiasari et al.38 in a double-blind randomized study in 120 patients

randomly divided into a unilateral spinal anaesthesia group (Group S) and an epidural

anaesthesia group (Group E) aimed at comparing haemodynamic changes and

complications in unilateral spinal anaesthesia and epidural anaesthesia below the T10

sensory level in unilateral surgeries. Systolic blood pressure (SBP), diastolic blood

pressure (DBP), mean arterial pressure (MAP), and heart rates were measured before and

immediately after the administration of spinal or epidural anaesthesia and then at 5, 10,

15, 20, 25, and 30 min intervals. SBP, DBP, and MAP values initially showed a

statistically significant downward trend in both groups (P = 0.001). The prevalence of

hypotension in Group S was lower than in Group E, and the observed difference was

statistically significant (P= 0.0001). The mean heart rate change in Group E was greater

than in Group S, although the difference was not statistically significant (P = 0.68). The

study concluded that haemodynamic stability, reduced administration of Ephedrine, a

simple, low-cost technique, and adequate sensory and motor block are major advantages

of unilateral spinal anaesthesia.

M. Al Malyan et al.39 in a study aimed to compare the effect of patient posture

during the induction phase of spinal anaesthesia, on block characteristics in eighty

patients, ASA I–II, scheduled for unilateral hernioplasty randomized into two groups.

Anaesthesia was performed in lateral position in Group 1 (G1) with operative side down

and in sitting position in Group 2 (G2) whose patients were then immediately turned on

their lateral side. All patients were maintained for 20 min in lateral position with their

operative side down. Hyperbaric Bupivacaine 1% 10 mg was used. Results showed

unilateral anaesthesia in 80% (32/40) and 12.5% (5/40) of G1 and G2 groups

respectively. The readiness for surgery was faster in G1 (P = 0.0001). The motor block in

the non-operative side was stronger in G2 (P =0.0001). The offset of sensory block was

10
 Review of Literature

faster in G1 (P = 0.0001). The offset of motor block was slower in G1 (P = 0.0008). Thus

they concluded that lateral posture during the induction of spinal anaesthesia is pivotal for

a higher success of unilateral block, a fast readiness to surgery, and a fast recovery.

Therefore, this technique can be considered feasible and time-saving for lower abdominal

and lower limb surgeries.

Dikshanand Dongre et al.40 in a prospective, randomized study to compare

between haemodynamic changes and time to first post-operative analgesia requirement in

patients undergoing unilateral and bilateral spinal anaesthesia for lower limb surgeries in

total 60 subjects divided amongst two groups equally, group A (n=30) received bilateral

anaesthesia and group B (n=30) received unilateral spinal anaesthesia. Onset, duration

and time to reach maximum height of sensory block, duration of analgesia and

haemodynamic variables were studied amongst two groups. They found that duration,

time to reach maximum height of sensory block, and duration of analgesia were longer in

group B, thus concluding that unilateral spinal anaesthesia offers more favourable

haemodynamic and post-operative outcome when compared with bilateral spinal

anaesthesia.

In view of contradictory results regarding unilateral spinal anaesthesia after vast

review of literature, we undertook this study. As there was paucity of data regarding

effects of reverse trendelenberg position on quality of USpA, we used reverse

trendelenberg position in one of the groups.

11
 Pharmacology

PHARMACOLOGY

Local anaesthetics are chemical compounds which are capable of reversibly

inhibiting the propogation of impulses in nerve cells.

BUPIVACAINE:

It was synthesized in 1957 by A.F. Ekenstam and was first clinically used in 1963

by L.J.Telivuo. It is one of the long acting local anaesthetic available.

C18H28N2O,HCL

2-piperidine carboxamide 1-butyl-N-(2,6-dimethyl phenyl)-hydrochloride monohydrate

Chemical structure of Bupivacaine

Bupivacaine hydrochloride is awhite, odourless, crystalline powder with a bitter,

numbing taste. The hydrochloride salt is available in solution. A preparation marketed

specifically for subarachanoid block use, contains 80% of dextrose by w/v.

Pharmacokinetics of Bupivacaine:

Bupivacaine is rapidly absorbed from the site of injection, the rate of rise in

plasma concentration and peak plasma concentration depends on the regional anaesthesia

technique being used.

12
 Pharmacology

Absorption: The site of injection, dose and addition of a vasoconstrictor determine

systemic absorption of Bupivacaine. The maximum blood level of Bupivacaine is related

to the total dose of the drug administered from any particular site.

Distribution: This can be described by a two compartment model. A) The rapid

distribution phase (phase alpha) is believed to be related to uptake by rapid equilibrating

tissue i.e., tissues that have high vascular perfusion. B) The slow distribution phase

(phase beta) is mainly a function of distribution to slowly equilibrating tissue,

biotransformation and excretion of the compound. Most highly perfused organs show

higher concentrations of the drug. Bupivacaine is rapidly excreted by lung tissues.

Though skeletal muscle does not show particular affinity for Bupivacaine, it is largest

reservoir of the drug.

Distribution characteristics:

T1/2 alpha (min)- 2.7.

T1/2 beta (min)- 28.

Volume of distribution at steady state (ltrs) -72.

Clearance (ltrs) - 0.47.

Biotransformation and excretion:

Bupivacaine undergoes enzymatic degradation primarily in the liver. The

excretion occurs via the kidneys. Renal perfusion and factors affecting urinary pH affect

urinary excretion. Less than 5% of unchanged drug is excreted via the kidney through

urine. The major portion of injected agent appears in urine in the form of

13
 Pharmacology

2,6,pipecolyloxylidine (PPx) which is N-dealkylated metabolite of Bupivacaine. Renal

clearance of this drug is related to its protein binding capacity and pH of urine.

Mechanism of action:

Bupivacaine like other local anaesthetics prevent the generation and the

conduction of the nerve impulse. Their primary site of action is the cell membrane. Local

anaesthetics block conduction by decreasing or preventing the large transient increase in

the permeability of excitable membranes to Na+ that normally is produced by slight

depolarization of the membrane. This action of local anaesthetic is due to their direct

interaction with voltage gated Na+ channels. As the anaesthetic action progressively

develops in a nerve, the excitability threshold gradually increases, the rate of rise of

action potential declines, impulse conduction slows, and the safety factor for conduction

decreases. These factors decrease the probability of propagation of the action potential,

and nerve conduction eventually fails.

Effects of Bupivacaine:

It is relatively free of side effects if administered in an appropriate dosage. It is

more cardiotoxic than lignocaine and this is made worse by hypoxia, hypercapnia and by

pregnancy.

Central Nervous System

CNS is more susceptible to Bupivacaine. The initial symptoms involve feeling of

light headedness and dizziness followed by visual and auditory disturbances.

Disorientation and occasional feeling of drowsiness may occur. Objective signs are

usually excitatory in nature which includes shivering, muscular twitching and tremors;

14
 Pharmacology

initially involving muscles of the face (perioral numbness) and part of extremities. At still

higher doses cardiovascular or respiratory arrest may occur.

Cardiovascular System:

High level of Bupivacaine prolongs conduction time through various parts of heart

and extremely high concentration will depress spontaneous pacemaker activity, resulting

in bradycardia and arrest. Cardiac resuscitation is more difficult following Bupivacaine

induced cardiovascular collapse and hypoxia along with acidosis which markedly

potentiates cardiac toxicity. Bretylium but not lignocaine could raise the ventricular

tachycardiac threshold that was lowered by Bupivacaine.

Respiratory System:

Respiratory depression may be caused if excessive plasma level is reached which

inturn results in depression of medullary respiratory center. Respiratory depression may

also be caused by paralysis of respiratory muscles as may occur in high spinal or total

spinal anaesthesia.

Autonomic Nervous System:

Myelinated preganglionic beta fibres have a faster conduction time and are more

sensitive to the action of local anaesthetic including Bupivacaine. Involvement of

preganglionic sympathetic fibres is the cause of widespread vasodilation and consequent

hypotension that occurs in epidural and paravertebral block. When used for conduction

blockade all local anaesthetic particularly Bupivacaine produces higher incidence of

sensory blockade than motor fibres.

15
 Pharmacology

Dosage:

Maximal dose is 2mg/kg body weight (25-30 mL 0.5% solution).

Bupivacaine is available in following concentration:

0.25%, 0.5% and 1%.

0.25% and 0.5% in isotonic solution.

0.5% in 80% of dextrose.

0.125% - 0.75% used for nerve block and epidural anaesthesia or analgesia.

Subarachnoid block, 0.5% or 0.75% plus 80% of dextrose to make solution Hyperbaric.

Adverse effects:

Adverse effects encountered in clinical practice are mostly due to over dosage and

inadvertent intravascular injection.

 CNS: nervousness, dizziness, blurring of vision, drowsiness, convulsion, respiratory

arrest.

 CVS: myocardial depression, hypotension, arrhythmia, ventricular type of conduction,

and SA node depression and cardiac arrest.

 Allergic reaction: urticaria, bronchospasm, hypotension.

16
 Aim and Objectives

AIM AND OBJECTIVES

Aim: A comparative prospective study of effect of 10 degree reverse trendelenberg

position on block characteristics and haemodynamic parameters in unilateral spinal

anaesthesia in knee and below knee orthopaedic surgeries.

Objectives:

To study the effect of 10 degree reverse trendelenberg position on:

 Block characteristics of unilateral spinal anaesthesia.

 Haemodynamics of patients under unilateral spinal anaesthesia.

17
 Material and Methods

MATERIAL AND METHODS

Study area: Department of Anaesthesiology, Dr.RPGMC, Kangra at Tanda, Himachal

Pradesh.

Study population: The study was conducted after getting approval from Protocol Review

Committee of Dr.RPGMC Tanda. The study was done in patients of ASA 1 & 2 status,

aged 20-65 years, scheduled for knee and below knee orthopaedic surgery under

subarachnoid block.

Study duration: The study was conducted for a period of 12 months including data

collection, data organization, presentation, data analysis and data interpretation.

Sample size: 60 patients reporting for operative procedures for below knee surgeries and

fulfilling our inclusion criteria were included in our study.

Type of study: Prospective, Randomised, Controlled. It was block randomization study.

Study tools: Sensory block assessment, bromage scoring and haemodynamic parameters.

Study Design: Randomised controlled prospective study.

Randomization: Randomization was done by computer generated table of six blocks

each having 10 random numbers.

Blinding: Anaesthesiologist doing procedure and assessment could not be blinded in this

study because of visible head tilt in one group.

Inclusion criteria:

1. Patients of age between 20-65 years of either sex.

2. ASA physical status 1 and 2.

18
 Material and Methods

3. Haemodynamically stable patients.

4. Scheduled for knee and below knee orthopaedic surgeries under subarachnoid block

in supine position.

Exclusion criteria:

The following classes of patients were excluded from the study:

1. ASA physical status grade > 2.

2. Patients having any history of cardiovascular, renal, hepatic, respiratory, endocrine and

neuromuscular disorders.

3. Patients having epilepsy, neurological or psychiatric disorders.

4. Patients having bleeding or coagulation disorders.

5. Patients having local spinal deformity or local infection.

6. Patients with known allergic to local anaesthetics.

7. Patient not consenting for regional anaesthesia.

8. Patients in which surgery was to be done in lateral position.

Pre-operative visit:

A thorough pre-anaesthetic check-up, including detailed history regarding

physical health, coexisting heart disease, current medication, allergies, previous

anaesthetic and surgical history was noted.

19
 Material and Methods

Thorough clinical examination was conducted and patient’s physical status and

vital parameters (pulse rate, blood pressure and respiratory rate) were recorded day before

surgery. Haemogram, fasting/ random blood sugar, renal function tests, 12 lead ECG

were done as per protocol followed at our institute. All the patients were informed in

preoperative visit in their vernacular language regarding the procedure to be carried on

them in the operative room and written consent was obtained.

Preanaesthetic medication: All patients were instructed to fast for at least 8 hours for

solid food and 2 hours for clear liquid before surgery. Premedication in form of tablet

Ranitidine 150 mg and tablet Alprazolam 0.25 mg was given at night and morning at 6

am on the day of surgery.

Anaesthetic technique:

Patients were shifted to the operation table and intravenous line was secured with

18 G cannula in forearm. Loading was done with 10 mL/kg of lactated ringer. Five lead

electrocardiography (E.C.G.), oxyhemoglobin saturation (SpO2) and noninvasive blood

pressure (NIBP) monitoring (systolic, diastolic and mean) were attached. All above

mentioned parameters (baseline) were recorded before giving subarachnoid block. Urine

output monitoring and temperature monitoring was done in surgeries lasting more than

two hours.

Under all aseptic precautions, an epidural catheter was inserted in L2-3

intervertebral space using 18 G Tuohy’s needle in lateral position. The catheter was fixed

after insertion of 4 cm in epidural space. Test dose of 2% of lignocaine with adrenaline

3cc was given. A subarachnoid puncture was performed using midline lumbar approach,

with patient in lateral position using 26 gauge Quincke BD dura cutting spinal needle

(0.45mm x 90mm) in L 3-4 intervertebral space. Drug was given slowly intrathecally at the
20
 Material and Methods

rate of 0.2mL/sec. Bevel end of spinal needle was kept facing downwards in lateral

position. The patient was then be turned supine with reverse trendelenberg after ten min

and kept as such for whole procedure. Reverse trendelenberg position of 10 degree was

derived using standard mathematical calculations. Intra operative fluid management was

done as per routine.

The patients were divided in two groups:

Group 1: First group was to lie in lateral position for 10 min after spinal block without

any reverse trendelenberg and was acting as control.

Group 2: The other group was to lie in lateral position for 10 min after spinal block, with

reverse trendelenberg of 10 degrees throughout the procedure.

Both groups were given 10 mg of Bupivacaine heavy 0.5% in subarachnoid block

in L3-4 intervertebral space. No sedation was given to any patient. Patients with

incomplete block/partial effect were excluded from the study.

Blood pressure, heart rate, respiratory rate and peripheral oxygen saturation

(SpO2) were monitored. It was recorded from time 0 that is the time following

completion of injection, every 5 min till final motor and sensory block was achieved or

till first 30 min, then at 1 hour duration of surgery.

Sensory block: Sensory block was checked bilaterally in mid-clavicular line by pin prick

method and loss of cold sensation with spirited cotton swab every 30 secs till onset of

sensory block, then every 5 min till regression to two segment below maximum level.

Onset of sensory block: It was taken as the time of injecting drug into subarachnoid

space till complete analgesia at the level of T 12 (Anterior superior iliac spine) bilaterally.

21
 Material and Methods

Maximum sensory block level: Maximum level of block after 20 min.

Two segment regression time: It was counted as time for regression of block to two

segments down from maximum block level.

Duration of sensory block: Time to regress to T12.

Duration of analgesia: Request for first analgesic dose requirement was also noted.

Motor block: Motor block were tested by the modified bromage scale.

0 No motor loss.

1 Inability to raise extended leg; able to move knee and feet.

2 Inability to raise extended leg and move knee; able to move feet.

3 Complete motor block.

Motor block was assessed every 30 secs till onset of motor block, then every 5

min till resolution of block (withheld during surgery). The onset of motor block was

taken as time from intrathecal injection to modified bromage score 3 and duration of

motor block was taken as time for regression of motor block from modified bromage

score 3 to 0.

The following adverse effects if occur were observed, noted and managed accordingly:

1. Hypotension (systolic < 90 mm Hg or mean blood pressure less than 20% of

baseline) was treated with Ephedrine 6 mg intravenous stat and repeated if required.

2. Bradycardia (heart rate < 45 beats per minute) was treated with injection Atropine

0.6 mg intravenous.

22
 Material and Methods

3. Respiratory depression (Respiratory rate < 8/minute)/ peripheral oxygen

Saturation (SpO2) (SpO2 < 90%) was treated with oxygen supplementation through

ventimask @ 4 L/minute. The total number of patients requiring Atropine and

Ephedrine along with total dose required were observed and recorded. Total amount

of intravenous fluid administered was also recorded.

Before starting this study, ethics committee clearance was obtained. Keeping in

view the following ICMR guidelines and Helsinki Declaration the consent form was

signed by the patients before they were shifted to operation theatre.

There was no alteration of anaesthetic or surgical management in any patient due

to this study. Spinal anaesthesia is being used for nearly over 100 years without any

harmful effects to the patients. Unilateral spinal anaesthesia has been found a very safe

alternative to spinal anaesthesia in elderly high risk patients. Bupivacaine is the most

commonly used drug for giving subarachnoid block worldwide. Our study was to use

only those methods and drugs which are essentially proven to be safe for the patients.

Concerned speciality was informed of the study.

According to the guidelines set up by ICMR (1994) and Helsinki Declaration

(modified 2000), the following points were followed in all patients enrolled in the study.

1. The patients involved in the research project were informed participants.

2. Each patient’s attendant was adequately informed of the aims, methods, the anticipated

benefits and potential risks of the study and the discomfort it may entail them and the

remedies thereof.

23
 Material and Methods

3. Every precaution was taken to respect the privacy of patient, the confidentiality of the

patient’s information and to minimize the impact of the study on his/her physical and

mental integrity and personality.

4. The patient was given the right to abstain from participation in the study or to withdraw

consent to participate at any time of the study without reprisal.

5. Due care and caution was taken at all stages of the research to ensure that the patient is

to put to minimum risk, suffer from no irreversible adverse effects and, generally, benefit

from and by the research or experiment.

6. Written informed consent was obtained from patient.

24
 Statistical Analysis

STATISTICAL ANALYSIS

Data was collected and entered in MS Excel 2007. Statistical analysis was

performed by Epi Info statistical software. Quantitative data was analysed using

independent t-test and paired data were analysed using Paired t-test. Qualitative data was

analysed using Chi square test and Fisher Exact test.

Level of significance: “P” is the level of significance

P>0.05 not significant

P<0.05 significant

P<0.01 highly significant

P<0.001 very highly significant

25
 Observations and Results

OBSERVATIONS AND RESULTS

The present study was carried out in the Department of Anaesthesia, Dr. Rajendra

Prasad Government Medical College, Kangra at Tanda (H.P.), after ethics committee

approval and written informed consent, with the aim of studying the effect of 10 degree

reverse trendelenberg position on block characteristics (sensory and motor block) and

haemodynamic parameters (blood pressure, heart rate, oxygen saturation) in unilateral

spinal anaesthesia in knee and below knee orthopaedic surgeries in 60 patients randomly

divided into 2 groups. It was a block randomization study. All patients had successful

spinal anaesthesia, so no patient was excluded from the study and thirty in each group

completed the study successfully.

The groups were as follows:

Group 1: First group was to lie in lateral position for 10 min after spinal block without

any reverse trendelenberg and was acting as control.

Group 2: The other group was to lie in lateral position for 10 min after spinal block, with

reverse trendelenberg of 10 degrees throughout the procedure.

Both groups were given 10 mg of Bupivacaine heavy 0.5% in subarachnoid block in L3-4

intervertebral space.

26
 Observations and Results

Figure 1: Flow chart of patients recruited and analyzed in two groups:

CONSORT 2010 Flow Diagram

Study subjects (n=60)

Excluded from study (=0)
RANDOMIZATION

Randomized (n= 60) into 2 groups

Allocation
2

Group 1 (supine) Group 2 (head up)

Allocated to intervention (n= 30) Allocated to intervention (n=30)
 Received allocated intervention (n=30)  Received allocated intervention (n=30)
 Did not receive allocated intervention  Didnot receive allocated intervention
(n=0) (n= 0)

DROP OUT

Group 1 Group 2
Drop out (n=0) Drop out (n=0)
Discontinued intervention (n= 0) Discontinued intervention (n= 0)

Analysis

Group 1 Group 2
Analysed (n=30) Analysed (n=30)
 Excluded from analysis (n=0)  Excluded from analysis (n=0)
)

27
 PATIENT DISTRIBUTION

head up, 30, 50% supine, 30, 50% patient distribution

supine
head up

Figure 2: Group wise distribution of patients.

 Observations and Results

Table 1: Group wise distribution of patients amongst two groups

S no. Group Description N (%)

1 Group 1 Patients were given 10 mg of Bupivacaine heavy (N=30) 50%

(Supine) 0.5% in subarachnoid block in L3-4 intervertebral

space.

2 Group 2 Patients were given 10 mg of Bupivacaine heavy (N=30) 50%

(Head up) 0.5% in subarachnoid block in L3-4 intervertebral

space.

28
 MEAN AGE

supine, 38.7
head up, 42.4 supine
head up

Figure 3: Mean age recorded amongst the two groups.

MEAN WEIGHT

head up, 58.6, 50% supine , 59.7, 50%

supine
head up

Figure 4: Mean weight distribution amongst the two groups.

 Observations and Results

Table 2: Demographic profile of patients amongst two groups

SN Characteristics Group 1 Group2 Statistical

(supine) (head up) significance

(N=30) (N=30)

1 Age (mean±SD) 38.7±12.73 42.4±11.71 P=0.2473

2 Weight (mean±SD) 59.7±5.71 58.6±5.28 P=0.4418

3 Height (mean±SD) 160±6.44 158.86±3.52 P=0.3984

4 BMI (mean±SD) 23.15±1.58 23.32±2.54 P=0.7573

5 ASA Status 1 26 22

4 8 P=0.1970
ASA Status 2

Both the groups were comparable in terms of age (P=0.4418), weight (P=0.39840), height

(P=0.7573) and BMI (P=0.7573). Mean age of patients was 38.7±12.73 years in Group 1

and 42.4±11.71 years in Group 2. Mean weight of patient was 59.7±5.71 kilograms in

Group 1 and 58.6±5.28 kilograms in Group 2.

29
 MEAN HEIGHT

head up, 158.86,

supine, 160, 50%
50% supine
head up

Figure 5: Mean height distribution amongst the two groups.

MEAN BMI

head up, 23.32,

supine, 23.15, 50%
50% supine
head up

Figure 6: Mean BMI distribution amongst the two groups.

 Observations and Results

The mean height of the patients was 160±6.44 centimeters in Group 1 and 158.86±3.52

centimeters in Group 2. Also the mean BMI was 23.15±1.58 in Group 1 and 23.32±2.54

in Group 2. Similarly both the groups had almost similar ratio of ASA grade 1(26) vs (22)

and ASA grade 2(4) vs (8) patients (table 2)

30
 160
SBP
140
130.8 132.06 127.8 128
124 124 124.36 125
124.6 126 124.36
122.56 124
120 120.63 122.9 118
BP in mm of Hg

100

80 Supine
Headup
60

40

20

0
Baseline 5min 10min 15min 20min 25min 30min 1 hour

Figure 7: Mean systolic blood pressure amongst the two groups.

 Observations and Results

HAEMODYNAMIC PARAMETERS

TABLE 3: Mean systolic blood pressure variation amongst two groups

SN Time Group 1 Group 2 P value

interval (supine) (head up)

(n=30) (n=30)

Mean SD Mean SD “P”

1. Baseline 125.03 10.84 120.06 13.86 0.2867

2. 5min 124 14.06 132.06 18.40 0.0616

3. 10min 124.6 11.63 124.36 20.93 0.9564

4. 15min 125 14.11 120.63 17.25 0.2869

5. 20min 126 10.27 122.9 12.92 0.3080

6. 25min 118 9.76 127.8 13.48 0.5321

7. 30min 128 19.40 122.56 8.94 0.1684

8. 1 hour 124 14.06 124.36 20.93 0.9586

As shown in table above and figure 9, the mean systolic blood pressures amongst the two

groups were comparable at baseline and throughout the surgery being 124±10.84 mm of

Hg in Group 1 and 130.8±13.86 mm of Hg in group 2 at baseline (P=0.0387). Similarly it

was 125±14.11 mm of Hg and 120.63±17.25 mm of Hg at 15 min (P=0.2869), 128±19.40

mm of Hg and 122.56±8.94 mm of Hg at 30 min (P=0.1684). Systolic blood pressures

were also comparable at 1 hour of the procedure being 124±14.06 mm of Hg and

124.36±20.93 mm of Hg amongst the two groups (P=0.9586).

31
 100
DBP
90
82.9
80 79.3 78.2 79.83 79.5 79.53 78.2
77.53
70
BP in mm of Hg

60
50 Supine

40 Headup

30
20
10
0
Baseline 5min 10min 15min 20min 25min 30min 1hour

Figure 8: Mean diastolic blood pressure variation amongst the two groups.
 Observations and Results

TABLE 4: Mean diastolic blood pressure variations amongst two groups

Time Group 1 Group 2 P value

SN interval (supine) (head up)

(n=30) (n=30)

Mean SD Mean SD “P”

1. Baseline 80 6.84 79.3 9.75 0.7488

2. 5min 80 6.89 77.53 10.42 0.2834

3. 10min 79 6.87 78.2 7.84 0.6760

4. 15min 77 7.63 79.83 7.71 0.1586

5. 20min 78 10.26 79.5 9.83 0.5659

6. 25min 76 9.72 79.53 8.48 0.9899

7. 30min 77 7.60 79.88 7.70 0.1588

8. 1 hour 76 9.72 78.2 7.84 0.3386

As shown in table above and figure 10, the diastolic blood pressures amongst the two

groups were comparable at baseline and throughout the surgery being 80±6.84 mm of Hg

in Group 1 and 79.3±9.75 mm of Hg in group 2 at baseline (P=0.7488). Similarly it was

77±7.63 mm of Hg and 79.83±7.71 mm of Hg at 15 min (P=0.1586), 77±7.60 mm of Hg

and 79.88±7.70 mm of Hg at 30 min (P=0.1588). Diastolic blood pressures were also

comparable at 1 hour of the procedure being 76±9.72 mm of Hg and 78.2±7.84 mm of Hg

amongst the two groups (P=0.3386).

32
 105
MAP VARIABILITY
100

96.46
96
95 95.38 95 94.41 94.07
BP in mm of Hg

92.52 92.95
92 91.71
90 90.7 90 90 supine
89.93 89.23 89.04
headup
85

80

75
Baseline 5min 10min 15min 20min 25min 30min 1hour

Figure 9: Mean arterial pressure variation amongst the two groups.

 Observations and Results

TABLE 5: Mean arterial pressure variations amongst the two groups

Time Group 1 Group 2 P value

SN interval (supine) (head up)

(n=30) (n=30)

Mean SD Mean SD “P”

1. Baseline 96 7.85 96.46 9.48 0.8386

2. 5min 92 8.61 95.38 11.78 0.2097

3. 10min 91.71 8.57 95 11.86 0.2232

4. 15min 89.93 12.38 94.41 10.26 0.1326

5. 20min 92.52 10.86 94.07 10.51 0.5765

6. 25min 90.7 13.39 92.95 7.53 0.4259

7. 30min 98 17.45 89.23 7.28 0.3476

8. 1hour 90 17.45 89.04 7.26 0.7818

Baseline mean MAP in Group 1 and 2 was 96±7.85 mm of Hg and 96.46±9.48 mm of Hg

respectively, showing no significant intergroup variations (P=0.8386). Throughout the

procedure the MAP was comparable. At 1 hour MAP value amongst the two groups was

90±17.45 mm of Hg in Group 1 and 89.04±7.26 mm of Hg in Group 2 (P=0.7818).

33
 100
90
HEART RATE
84.86
83 83.4
80 82
80.9 81 80
77.33 79 76.86 78.56
78
75.16 76
75.65
73
HR in beats per minute

70
60
50 supine

40 headup

30
20
10
0
Baseline 5min 10min 15min 20min 25min 30min 1 hour

Figure 10: Heart rate (HR) variation amongst the two groups.
 Observations and Results

TABLE 6: Heart rate variability amongst the two groups

Time Group 1 Group 2 P value

SN interval (supine) (head up)

(n=30) (n=30)

Mean SD Mean SD “P”

1. Baseline 83 13.69 84.86 19.18 0.6672

2. 5min 82 11.50 80.9 17.64 0.7758

3. 10min 83.4 10.71 77.33 13.69 0.0609

4. 15min 79 12.43 75.16 14.57 0.2768

5. 20min 81 9.97 84.82 19.19 0.6677

6. 25min 80 6.88 76.86 9.43 0.1461

7. 30min 78 8.20 78.56 11.59 0.8297

8. 1 hour 76 7.77 75.65 11.89 0.8749

As shown in table 6 and figure 11, Heart rate in both the groups at baseline and at

different intra operative time intervals were comparable in both groups being 83±13.69

beats per minute in Group 1 and 84.86±19.18 beats per minute in group 2 at baseline

(P=0.6672). Similarly it was 79±12.43 beats per minute and 75.16±14.57 beats per

minute at 15 min (P=0.2768), 78±8.20 beats per minute and 78.56±11.59 beats per minute

at 30 min (P=0.8297). Heart rate were also comparable at 1 hour of the procedure being

76±7.77 beats per minute and 75.65±11.89 beats per minute amongst the two groups

(P=0.8749).

34
 Observations and Results

TABLE 7: Comparison of block characteristics amongst the two groups

SN VARIABLE GROUP 1 GROUP 2 SIGNIFICANCE

(n=30) (n=30) OF DIFFERENCE
GROUPS (1/2) Supine Supine Head up Head up
SUBGROUPS (ND) (D) (ND) (D)
(ND)/(D)
1 Onset of 160± 125.66± 170± 143± P=0.4716
sensory 55.20 49.94 51.62 45.04 P=0.1632
block (secs)
2 Maximum T4 0 1 0 0
sensory T5 1 1 0 0
block level
T6 10 13 3 4
(number) P=0.0001
T7 1 1 3 4
P=0.0001
T8 15 14 10 10
T9 2 0 14 12
Segments 4.83± 5.13±1.1 3.83± 4.02± P=0.0001
3 blocked 1.17 6 0.982 1.05 P=0.0001
above T-12
4 Onset of motor 311± 297.66±6 289.66±91 279.66±63.4 P=0.3066
block (secs) 72.59 2.7 .51 3 P=0.2737
5 Two segment 62.5± 72± 7.94 78.17± 86.16± P=0.0008
regression time 8.97 22.67 12.50 P=0.0001
(min)
6 Duration of sensory 108.16± 123.33±1 128.5±22. 144± 18.21 P=0.0006
block (min) till T12 20.9 7.6 67 P=0.0001

7 Duration of motor 70.33±1 80.33±11 75.33 85.66 ±10.8 P=0.1426

block (min) 1.6 .0 ±15.80 P=0.0648
8 Analgesia duration 165.4±6.79 180.13±8.47 P=0.0001

35
 SENSORY BLOCK ONSET

200 170
160
143
150 125.66
UP
seconds

100 DOWN

50

0
Supine Headup

Figure 11: Onset of sensory block amongst two groups.

 Observations and Results

TABLE 8: Onset of sensory block (sec) amongst the two groups

SN Time Group 1 Group 2 P value

interval (supine) (head up)

(n=30) (n=30)

Mean SD Mean SD “P”

1. Nondependent 160 55.20 170 51.62 P=0.4716

(ND)

2. Dependent (D) 125.66 49.94 143 45.04 P=0.1632

As shown in table 8 and figure 12, onset of sensory block was faster in Group 1 (D) than

in Group 2 (D), (125.66±49.94 sec) and (143±45.04 sec) respectively. Among

nondependent groups, onset was slightly faster in Group 1 (160±55.20 sec) as compared

to Group 2 (170±51.62 sec). The results showed faster onset of sensory block in Group 1,

being earlier on the dependent side but was not statistically significant. Intra group

comparisons showed faster onset in dependent side than in nondependent side.

36
 TOTAL SEGMENTS BLOCKED (ABOVE T-12)

6 5.13
4.83
5
number of segments

3.66 3.73
4
UP
3 DOWN
2

0
Supine Headup

Figure 12: Total segments blocked amongst the two groups.

 Observations and Results

TABLE 9: Total number of segments blocked ( above T-12) amongst

two groups

Group 1 Group 2 P value

SN (supine) (head up)
(n=30) (n=30)
Mean SD Mean SD “P”
1. Nondependent 4.83 1.17 3.83 0.982 P=0.0001
(ND)
2. Dependent (D) 5.13 1.16 4.02 1.05 P=0.0001

As shown in table 10 and figure 14, number of segments blocked were more in Group 1

(D) than in Group 2 (D);(5.13±1.16) and (4.02±1.05) respectively. Among nondependent

groups, number of segments blocked in Group 1 (4.83±1.17) were higher as compared to

Group 2 (3.83±0.982). The results showed higher number of segments blocked in Group

1 being more on the dependent side. The results were statistically significant (P=0.0001).

Intra group comparisons showed higher block levels in dependent side as compared to

nondependent side.

37
 TOTAL SENSORY BLOCK DURATION

144
160
123.33 128.5
140
108.16
120
100 UP
minutes

80 DOWN
60
40
20
0
Supine Headup

Figure 13: Total sensory block duration amongst the two groups.
 Observations and Results

TABLE 10: Total duration of sensory block (min) among two groups

Time interval Group 1 Group 2 P value

SN (supine) (head up)

(n=30) (n=30)

Mean SD Mean SD “P”

1. Nondependent (ND) 108.16 20.98 128.5 22.6 P=0.0006

2. Dependent (D) 123.33 17.63 144 18.21 P=0.0001

As shown in table 11 and figure 15, total duration of sensory block was more in Group 2

(D) than in Group 1 (D);(144±18.21 min) and (123.33±17.63 min) respectively. Among

nondependent groups, total duration of sensory block in Group 1 was (108.16±20.98 min)

as compared to Group 2 (128.5±22.6 min). The results showed higher duration of sensory

block in Group 2 being more on the dependent side. The results were statistically

significant (P=0.0001). Intra group comparison showed higher total duration of sensory

block on dependent side as compared to nondependent side.

38
 ANALGESIA DURATION

185 180.13
180
175
minutes

ANALGESIA
170 165.4

165
160
155
Supine Headup

Figure 14: Total duration of analgesia amongst the two groups.

 Observations and Results

TABLE 11: Total analgesia duration (min) amongst the two groups

Group 1 Group 2 P value

SN (supine) (head up)
(n=30) (n=30)
1 Mean SD Mean SD “P”
2 165.4 6.79 180.13 8.47 P=0.0001

As shown in table 12 and figure 16, total duration of analgesia was more in Group 2 than

in Group 1 (165.4±6.79 min) and (180.13±8.47 min) respectively. The results were

statistically significant (P=0.0001).

39
 MOTOR BLOCK ONSET(SEC)

320 311.66

310
297.66
300 289.66 UP
seconds

290 279.66 DOWN

280

270

260
Supine Headup

Figure 15: Onset of motor block (secs) amongst the two groups.
 Observations and Results

TABLE 12: Motor block onset time (sec) amongst the two groups

Time interval Group 1 Group 2 P value

SN (supine) (head up)

(n=30) (n=30)

Mean SD Mean SD “P”

1. Nondependent (ND) 311.66 72.59 289.66 91.51 P=0.3066

2. Dependent (D) 297.66 62.73 279.66 63.43 P=0.2737

As shown in table 13 and figure 17, onset of motor block was faster in Group 2 (D) than

in Group 1 (D), (279.66±63.43 sec) and (297.66±62.73 sec) respectively. Among

nondependent groups, onset was slightly faster in Group 2 (289.66±91.51 sec) as

compared to Group 1 (311.66±72.59 sec). The results showed faster onset of motor block

in Group 2 being earlier on the dependent side but was not statistically significant

(P=0.2737). Intra group comparisons showed faster onset in dependent side as compared

to nondependent side.

40
 DURATION OF MOTOR BLOCK

100 85.66
80
75.33
70
80

60 UP
minutes

DOWN
40

20

0
Supine Headup

Figure 16: Total duration of motor block (min) amongst the two groups.
 Observations and Results

TABLE 13: Total duration of motor block (min) amongst two groups

Time interval Group 1 Group 2 P value

SN S(supine) (head up)

(n=30) (n=30)

Mean SD Mean SD “P”

1. Nondependent 70 11.67 75.33 15.80 P=0.1426

(ND)

2. Dependent 80 11.06 85.66 10.88 P=0.648

(D)

As shown in table 14 and figure 18, total duration of motor block was slightly more in

Group 2 (D) than in Group 1 (D);(85.66±10.88 min) and (80±11.06 min) respectively.

Among nondependent groups, total duration of motor block in Group 1 was (70±11.67

min) as compared to Group 2 (75.33±15.80 min). The results showed higher duration of

motor block in Group 2 being more on the dependent side. The results were statistically

non-significant (P=0.648). Intra group comparisons showed higher total duration of motor

block in dependent side as compared to nondependent side.

41
 Observations and Results

TABLE 14: Hypotension amongst the two groups

Hypotension Group 1 (supine) Group 2 (head up)

Yes 4 0

No 26 30

Also clinically relevant hypotension occurred in only 4 patients in Group 1 and none in

Group 2 signifying higher segmental block levels in Group 1 than in Group 2. There was

no bradycardia in both the groups.

42
 Discussion

DISCUSSION

Orthopaedic anaesthesia plan requires customization as per patient’s need for safe

outcome. Low dose bilateral and unilateral single shot spinal anaesthesia (USpA) with

epidural anaesthesia has advantages over conventional spinal anaesthesia. It provides

more stable haemodynamics with provision of intraoperative activation of epidural

anaesthesia and postoperative analgesia.16,41

Quest for controlling height of spinal block is as old as history of spinal

anaesthesia. There has been a black period for spinal anaesthesia during its discovery

because of dreadful complication like hypotension, bradycardia and PDPH.3, 6 Position of

the patient might play a crucial role in determining final levels of motor and sensory

block. Unilateral spinal anaesthesia is a promising alternative to traditional, widely used

technique of central neuraxial blocks, as it markedly restricts the anaesthetized area,

thereby, decreasing the risk of adverse events and complications.42

Numerous studies have been conducted to see the effects of spinal blockade.

Hypotension is the most frequent side effect of spinal anaesthesia, occurring in more than

30% of patients. Ward et al.43 reported a decrease in mean arterial blood pressure of

21.3% of the base line following spinal anaesthesia.

Unilateral spinal anaesthesia is given with aim to limit distribution of spinal block

only to the operated side for surgeries involving only one lower limb. It is achieved by

giving minimal required dose of intrathecal agent so that only nerve roots supplying

specific area and only areas that require to be anaesthetized are affected. It has been

suggested that a unilateral distribution of spinal anaesthesia can be attempted using lateral

decubitus position with small doses of hyperbaric spinal anaesthetic solution using small

43
 Discussion

gauge directional pencil point needles, injecting the drug slowly over long time and

maintaining the lateral decubitus position for 15 to 20 min.44,45 Also previous studies have

shown that injection of 10 mg (2 mL) Hyperbaric Bupivacaine can provide block of

duration approximately two to three hours for operations above the knee.13,14 Above

findings have been supported by studies by Casati et al.16, Esmaoglu et al.46, Moosavi

Tekye et al.32 and Chohan et al.27

Therefore, we enrolled 60 ASA grade 1/2 patients scheduled for knee or below

knee orthopaedic surgeries randomly divided into two groups of 30 each. Study was

carried out in Department of Anaesthesiology, DR.RPGMC Kangra at Tanda spanning

over a period of 12 months. The two groups were:

Group 1 (supine): Lateral position for 10 min after spinal block without any

reverse trendelenberg and acted as control.

Group 2 (head up): Lateral position for 10 min after spinal block, with reverse

trendelenberg of 10 degrees throughout the procedure.

Both the groups were further subdivided into 2 groups as dependent (D) and

nondependent (ND).

Demographic profiles of both the groups were comparable (Age, height, weight,

body mass index). Mean age amongst the two groups was 38.7±12.73 and 42.4±11.71

years respectively. Similarly mean weight was 59.7±5.71 kilograms in Group 1 and

58.6±5.28 kilograms in Group 2 respectively. The average height was 160±6.44 and

158.86±3.52 centimeters amongst the two groups. Similarly BMI was 23.15± 1.58 and

23.32±2.54 amongst the two groups (P=0.7573). There was no significant difference

between the groups in terms of the haemodynamic parameters. Heart rates amongst the

44
 Discussion

two groups preoperatively and at 15, 30 and 60 min of surgery was comparable being

83±13.69, 79±12.43, 78±8.20, 76±7.77 in Group 1 and 84.86±19.18, 75.16±14.57,

78.56±11.59, 75.65±11.89 in Group 2 respectively. Similarly the systolic blood pressures

at baseline, 15, 30 and 60 min of surgery were comparable and not statistically significant

being 124±10.84, 125±14.11, 128±19.40, 124±14.06 in Group 1 and 130.8±13.86,

120.63±17.25, 122.56±8.94, 124.36±20.93 in Group 2 respectively. Also the diastolic

blood pressure amongst the two groups was comparable being 80±6.84, 77±7.63,

79±8.04, 76±9.72 in Group 1 and 79.3±9.75, 79.83±7.71, 82.9±6.19, 78.2±7.84 in Group

2 respectively. Small doses and unilateral position leading to low levels of block may

have resulted in very few cases of hypotension, that too in Group 1 only.

Mean onset of sensory block: Present study revealed that mean time taken to

achieve T12 sensory block within intra group 1 was 160±55.20 sec in ND and

125.66±49.94 sec in D respectively. While in intra group 2, it was 170±51.62 sec in ND

and 143±45.04 sec in D. Also the intergroup variation was 160±55.20 sec (Group 1) and

170±51.62 sec (Group 2) in ND subgroups while it was 125.66±49.94 sec (Group 1) and

143±45.04 sec (Group 2) in D subgroup. Thus onset of sensory block was faster in Group

1 as compared to Group 2. Among D and ND subgroups, onset was faster in D subgroup

as compared to ND subgroup. It may be attributed to higher concentration of Hyperbaric

drugs on depend side leading to faster onset of block. A similar study by Faruk Cicekci et

al.48 found similar results with mean onset of sensory block being 3.34±1.54 min in their

study group thus supporting our results.

Maximum sensory block level: In present study, the maximum block levels

remained confined to T8 level in most of the patients in Group 2, producing a more dense

sensory block in comparison to Group 1. Results were statistically significant (P=0.0001).

45
 Discussion

Similar results were obtained by Jyoti Sandeep Magar et al.36 in studies in unilateral

spinal anaesthesia.

Average number of segments blocked: Present study showed that average

number of segments blocked were 4.83±1.12 in Group 1 subgroup ND and 5.13±1.16 in

subgroup D, similarly in Group 2 average number of segments blocked were 3.83±0.98 in

subgroup ND while it was 4.02±1.05 in subgroup D. Also, the intergroup variation was

4.83±1.12 and 3.83±0.98 in ND subgroups while it was 5.13±1.16 and 4.02±1.05 in D

subgroup. Results were statistically significant with P value of 0.0001 in both the groups.

Thus, we could conclude that giving slight head up tilt during lateral position can help in

controlling level of block in both dependent and nondependent sides.

Time taken for two segment regression: In present study, we found that time

taken for regression within intra group 1 was 62.5±8.97 min in ND and 72±7.94 min in D.

While in intra group 2, it was 78.17±22.67 min in ND and 86.16±12.50 min in D. Also

the intergroup comparison showed that two segment regression time was more in Group 2

(ND) and (D) as compared to Group 1 (ND) and (D) respectively. Statistically, there was

a significant difference among the two groups (P=0.0001). So, we conclude that giving

head up position may prolong two segment regression time in Group 2 as compared to

Group 1. One such study done by Lee et al. 34 using head up position showed similar

results in caesarean section. Our study was supported by another study by Borghi B et

al.47 with two segment regression time of 96±3.2 min.

Total duration of sensory block: In our study, we found that the total duration of

sensory block within intra group 1 was 108.16±20.9 min in ND and 123.33±17.6 min in

D subgroup. While in intra group 2, it was 128.5±22.67 min in ND and 144±18.21 min in

D subgroup respectively. Also the intergroup variation was 108.16±20.9 min and

46
 Discussion

128.5±22.67 min in ND subgroups while it was 123.33±17.6 min and 144±18.21 min in

D subgroup respectively. Total duration of sensory block was maximum in Group 2

subgroup (D) (144±18.21)min and minimum in Group 1 subgroup (ND) (108.16±20.9

min). This difference was statistically significant (P=0.0001). Similar results were

obtained by Jyoti Sandeep Magar et al.36 showing total duration of sensory block of

137.67±13.50 min in their study. However no studies could be found involving use of

head up position during spinal anaesthesia for lower limb surgeries. Thus, we conclude

that giving reverse trendelenberg position during surgery can help in prolonging duration

of sensory block, at the same time limiting the block levels.

Onset of motor block (sec): In our study, we found that the mean time taken to

achieve optimum motor block (bromage3) within intra group 1 was 311±72.59 sec in ND

and 297.66±62.7 sec in D. While in intra group 2, it was 289.66±91.51 sec in ND and

279.66±63.43 sec in D. Also the intergroup variation was 311±72.59 sec and

289.66±91.51 sec in ND subgroups while it was 297.66±62.7 sec and 279.66±63.43 sec in

D subgroup respectively. Result was not statistically significant (P=0.0648). Thus, we

concluded that onset of motor block was faster in Group 1 on dependent side, suggesting

that position of patient may play a role in onset of motor block.

Duration of motor block (min): In our study, we found that motor block duration

within intra group 1 was 70.33±11.6 min in ND and 80.33±11.0 min in D. While in intra

group 2 it was 75.33±15.80 min in ND and 85.66±10.8 min in D. Also the intergroup

variation was 70.33±11.6 min and 75.33±15.80 min in ND subgroups while it was

80.33±11.0 min and 85.66±10.8 min in D subgroup. The result was not statistically

significant (P=0.0648).Thus showing that reverse trendelenberg position may produce

longer duration of motor block.

47
 Discussion

Analgesia duration (min): Analgesia duration was significantly prolonged in

Group 2 being 180.13±8.47 min as compared to Group 1 being 165±6.79 min and was

statistically significant (P=0.0001). This study has been supported by similar study by

Jyoti Sandeep Mager et al.36 showing analgesia duration of 172.67 min in their study.

Thus we concluded that giving reverse trendelenberg position may produce increased

duration of motor block.

Complications:

Also throughout the surgery there was no requirement of vasopressor agents in

Group 2 while four patients in Group 1 required vasopressors for hypotension. There was

no episode of significant bradycardia requiring treatment in both the groups.

Although studies have been done on feasibility of unilateral spinal anaesthesia, but

in reality it seems to be a myth in anaesthesia practice as blind drug injection into

subarachnoid space does not precisely confirm how the drug is going to spread towards

one side only, despite knowing the fact that subarachnoid space is not limited by any

boundaries. But, a study carried out in 2000 by Borghi B et al.47 on 51 outpatients

scheduled for knee arthroscopy compared 3 groups using 4 mg, 6 mg or 8 mg of 0.5%

Hyperbaric Bupivacaine. Results showed that the smaller dose (4 mg) was sufficient for

good quality spinal anaesthesia lasting about 61±19 min. In Groups using 4 and 6 mg

drug, strict unilateral anaesthesia was reported among 90% and 85% of patients

respectively, in whom the level of sensory block on the operative side was T10 and T8,

respectively. This study supports the claim that USpA is truly possible.

Another important aspect to consider whenever trying to perform unilateral spinal

anaesthesia is the direction of the local anaesthetic solution flowing out of the spinal

needle. It has been demonstrated that the use of directional pencil point needles together
48
 Discussion

with a slow injection speed (about 3 mL/min) minimizes turbulence so that anaesthetic

solution and CSF mix to produce a homogeneous mixture with balanced baricity.

There have been very few studies in which reverse trendelenberg position has

been used for controlling height of spinal block using hyperbaric drugs.35 None of studies

have used head up position along with unilateral spinal anaesthesia. Moreover, extensive

pubmed search did not yield any randomized studies in the literature comparing supine

and head up positions for unilateral SA for lower limb orthopaedic surgery.

The results from this study indicates that unilateral spinal anaesthesia provides

good quality block with T10 sensory level and motor block of modified bromage score 3

for lower limb orthopaedic surgery. We did not find any randomized studies in the

literature comparing with unilateral SA for lower limb orthopaedic surgery using reverse

trendelenberg position in one of the groups.

One major limitations of our study was the use of 10 mg of drug which may be

too high to produce a true hemispinal. Future studies with low dose may be required to

further validate if USpA is truly feasible or not. Also results of reverse trendelenberg

position can’t be extrapolated to other population groups like obstetric patients due to

their coherent physiological changes. Further larger sample sized clinical trials are

required to validate our hypothesis. So we recommend further studies using reverse

trendelenberg position in geriatric and other high risk groups with a hope of finding a way

out of what has not been achieved perfectly till now since the inception of spinal

anaesthesia use a century ago.

49
 Summary

SUMMARY

Present study was carried out on 60 patients belonging to ASA I/ II status, aged

between 18-65 years, scheduled for knee and below knee orthopaedic surgeries under

subarachnoid block. The patients were randomly divided ( block randomisation) into two

groups of 30 patients each. The study was carried out in Department of Anaesthesiology,

DR. RPGMC Kangra at Tanda spanning over a period of 12 months. Both the groups

received 10 mg (2 mL) Hyperbaric Bupivacaine 0.5% intrathecally. While Group 1

(supine) was kept in lateral position for 10 min after spinal block without any reverse

trendelenberg and acted as control, Group 2 (head up) was kept in lateral position for 10

min after spinal block, with reverse trendelenberg of 10 degrees throughout the

procedure.

We studied the demographic profiles of the two groups to find out if at all the

groups under study were comparable in terms of age, sex, weight, height, BMI and ASA

status. Haemodynamic parameters were studied to draw comparisons in relation to heart

rate variability, systolic blood pressures, diastolic blood pressures and mean arterial

pressures as baseline values and then throughout the procedure. The block characteristics

were studied in the two groups for the onset of sensory and motor block, the time for two

segment regression of sensory block and the total duration of sensory and motor block.

Intra group comparisons were also done to draw conclusion regarding any significant

differences in block characteristics in dependent and nondependent sites.

The following results were obtained from the study:

1. Both the groups were comparable in demographic parameters namely age, BMI and

ASA status and there were no intergroup variations.

50
 Summary

2. Both the groups were comparable in haemodynamic profiles intra operatively namely

heart rate, MAP, SBP and DBP.

3. The onset of sensory block was faster in Group 1 (D) (125.66±49.94 sec) than in

Group 2 (D) (143 ±45.04 sec), (P=0.4716). Among nondependent groups, it was non-

significantly higher in Group 1 {Group 1 (ND): 160±55.20; Group 2(ND):

170±51.62}.

4. The onset of motor block was non-significantly faster in Group 2 (D) as compared to

Group 1 (D) being more so in subgroup (D) (P=0.2737). Among nondependent

groups, motor onset was correspondingly faster in Group 2 as compared to Group 1.

5. The maximum sensory block level was higher in Group 1 (D) as compared to Group 2

(D) (P=0.0001). Among nondependent groups, correspondingly it was higher in

Group 1 (ND).

6. Number of average segments blocked were higher in Group 1 (D) as compared to

Group 2 (D) (P=0.0001). Among nondependent groups, correspondingly it was higher

in group 1 (ND).

7. The time for two segment regression was more in Group 2 (D) (86.16±12.50 min) as

compared to Group 1 (D) being (72±7.94 min). Among nondependent groups,

correspondingly it was longer in Group 2 (ND).

8. The duration of sensory block was more in Group 2 (D) (144±18.21 min) than in

Group 1 (123.33±17.6 min) (P=0.0001). Among nondependent groups,

correspondingly it was longer in Group 2.

51
 Summary

9. The duration of motor block was more in Group 2 (D) (85.66±10.8 min) than in

Group 1 (D) (80.33±11.0 min). Among nondependent groups, correspondingly it was

more prolonged in Group 2 than in Group 1.

10. The total duration of analgesia was significantly more in Group 2 (180.13±8.47min)

than in group 1 (165.4±6.79 min) (P=0.0001).

11. There were no cases of significant hypotension in Group 2 as compared to Group 1,

where four patients had episodes of hypotension requiring Ephedrine. There was no

episode of significant bradycardia in any of groups.

52
 Conclusion

CONCLUSION

Hence from above study, we conclude that 10 mg of 0.5% Bupivacaine can’t

produce USpA truly. Although block is more dense on dependent side than the

nondependent side. Low dose may be required for true hemispinal block to really happen.

We also conclude that keeping patient in reverse trendelenberg of 10 degree immediately

after giving spinal anaesthesia significantly limits the level of sensory block.

It can be clinically advantageous in controlling block height in high risk patients

involving lower limb surgeries where levels above T10 are rarely required. At the same

time, low levels of block do not lead to shorter duration of analgesia. The density of block

confined to lower lumbosacral subarachnoid space only, may lead to prolonged duration

of analgesia along with a better haemodynamic stability.

One major limitations of our study was the use of 10 mg of drug which may be

too high to produce a true hemispinal. Further studies with low dose may be required to

validate if USpA is truely feasible or not.

Also, results of reverse trendelenberg position can’t be extrapolated to other

population groups like obstetric patients due to their coherent physiological changes.

Further larger clinical trials with larger sample size are required to validate our

hypothesis. So, we recommend further studies using reverse trendelenberg position in

geriatric and other high risk groups with a hope of finding a way out of what has not been

achieved perfectly till today since the inception of spinal anaesthesiaa century ago.

53
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59
 Annexures

ANNEXURES
UNDERTAKING BY THE PRINCIPAL INVESTIGATOR

 I have reviewed the protocol and agree that it contains all the necessary information to

conduct the study. I will not begin the study until all necessary ethics committee and

regulatory approvals have been obtained.

 I agree to conduct the study in accordance with the current protocol. I will not

implement any deviation from or changes of the protocol without agreement by the

sponsor and prior review and documented approval/ favorable opinion from the ethics

committee of the amendment, except where necessary to eliminate an immediate

hazard(s) to the trial subjects.

 I agree to report to personally conduct and/or supervise the study. I will ensure that

the requirements relating to obtaining informed consent and ethics committee review

and approval specified in the GCP guidelines are met.

 I agree to report to the ethics committee all serious adverse events that occur during

the course of the study.

 I have read and understood all available information related to the study including the

potential risks and side effects of the drugs and procedures that will be used in the

study.

 I agree to ensure that all the associates, colleagues, and employees assisting in the

conduct of the study are suitably qualified and experienced and they have been

informed about their obligations in meeting their commitments in the study.

 I agree to maintain adequate and accurate records and to make those records available

for audit by ethics committee, licensing authority or sponsors, if asked for.

60
 Annexures

 I agree to promptly report to the ethics committee all changes in the study related

activities and all the unanticipated problems involving risks to human subjects or

others.

 I will maintain confidentiality of the identification of all participants and assure

security and confidentiality of study data.

 I agree to comply with all other requirements, guidelines and statutory obligations as

applicable to clinical investigators participating in the clinical study.

Signature of the Investigator_____________________ Date

61
 Annexures

ANNEXURE- A

RECORD FORM

DEPARTMENT OF ANAESTHESIOLOGY DR RPGMC, TANDA KANGRA

Patient Profile:

Serial No. Group Date

Name Age/Sex C.R.No.

Weight Height ASA grade

Diagnosis:

Operation:

Physical Examination:

Pulse Blood Pressure Respiratory

Rate

Respiratory System

Cardiovascular System

Spine

Investigations:

Haemoglobin

Urea/Creatinine

Blood Sugar/ECG

Urine

X Ray Others, if any

62
 Annexures

BASE LINE VITALS BEFORE SPINAL ANAESTHESIA:

1. Heart rate
Systolic
2. Blood Pressure Diastolic
Mean arterial
3. Peripheral Oxygen Saturation in %
(SPO2)
4. Respiratory Rate

INTRAOPERATIVE MONITORING

TIME HAEMODYNAMICS Atropine Ephedrine Supplemental Sedation

(Min) 0.6mg iv mg IV O2 @ 4l/min. score
H SBP DBP MAP SPO2 RR/
R mmHg mmHg mmHg % Minute
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100

TOTAL DOSE

HR: Heart rate SBP: Systolic blood pressure, DBP: diastolic blood pressure, MAP: mean
arterial pressure, SPO2%age: oxyhaemoglobin saturation, RR: Respiratory rate

SENSORY ASSESSMENT (loss of pinprick sensation)

63
 Annexures

Parameter Right Left

Onset of sensory block
Maximum sensory block level
Two segment regression time
Duration of sensory block
Duration of analgesia

MOTOR ASSESSMENT (modified bromage scale)

Parameter Right Left

Onset of motor block
Duration of motor block

ANY SIDE
EFFECT………………….....................................……………………………. Total
amount of intravenous fluids administered…………………….

REMARKS IF ANY

(Supervisor) (Investigator)

64
 Annexures

INFORMED CONSENT

I…………………………………………………son/daughter/wife of
………………….resident of ………………………..give my full, free and voluntary
consent to be included as a subject in the study entitled “Comparative double blind
prospective study of effects of 10 degree reverse trendelenberg position on block
characteristics and haemodynamic parameters in unilateral spinal anaesthesia in
orthopaedic patients undergoing knee and below knee surgeries.’’ The contents of study
have been read carefully by me / explained in detail to me, in a language that I
comprehend, and I have fully understood the contents. I confirm that I had the
opportunity to ask questions.

The nature and purpose of the study with its potential risks/benefits and expected duration
of the study along with other relevant details of the study have been explained to me in
detail. I understand that my participation is voluntary and that I am free to withdraw at
any time, without giving any reason, without my medical care or legal right being
affected.

I understand that the information collected about me from my participation in this

research and sections of any of my medical notes may be looked at by responsible
individuals. I give permission for these individuals to have access to my records.

I agree to take part in the above study.

…………………… Date:

(Signature/Left Thumb Impression) Place:

Name of the Participant:

Husband Name:

Complete postal address…………………………………………….

Date:

Signatures of the Investigator Place:

65
 Annexures

PATIENT INFORMATION SHEET

PRINCIPAL INVESTIGATOR Dr. Manuj Kumar

CO-INVESTIGATORS Dr. R. K. Verma

Dr. Bhanu Awasthi

Dr. Shyam Bhandari

Name of Participant: ……………………….

Title: A comparative, double blind, prospective study of effect of 10 degree reverse

trendelenberg position on block characterstics and haemodyanamic parameters in
unilateral spinal anaesthesia in knee and below knee orthopaedic surgeries.

You are invited to take part in this research study. The information in this document is
meant to help you decide whether or not to take part. Please feel free to ask if you have
anyqueries or concerns.

You are being asked to participate in this study being conducted in Department of
Anaesthesiology, Dr. RPGMC Tanda, because you satisfy our eligibility criteria which
are:

(1) To undergo knee and below knee orthopaedic surgery under subarachnoid block.

(2) Age group 20-65.

(3) No co-morbidities and other illness.

You will be one of the patients, we plan to recruit in this study. You will be assigned to
either of the two study groups according to the computer generated random number.

What is the purpose of research?

Comparative double blind prospective study of effects of 10 degree reverse trendelenberg

position on block characteristics and haemodynamic parameters in unilateral spinal
anaesthesia in orthopaedic patients undergoing knee and below knee surgeries.

66
 Annexures

Participant’s initials:

Possible risks to you

There are minimal chances of adverse effect of these drugs.

Possible benefits to you

You are not expected to get any benefit.

Compensation

No.

Possible benefits to other people

The results of the research may provide benefits to the society in terms of advancement of
medical knowledge and/or therapeutic benefit to future patients.

The alternatives you have

If you do not wish to participate, you have the alternative of getting the standard
treatment for your condition.

Cost to the participant

There will be no added cost to you for the said study.

What should you do in case of injury or a medical problem during this research
study?

Your safety is the prime concern of the research. If you are injured or have a medical
problem as a result of being in this study, you should contact one of the investigators
listed at the end of the consent form. You will be provided the required
care/treatment.You will be entitled to your legal rights besides this.

Confidentiality of the information obtained from you:

You have the right to confidentiality regarding the privacy of your medical information
(personal details, results of physical examinations, investigations, and your medical

67
 Annexures

history). By signing this document, you will be allowing the research team investigators,
other study personnel, sponsors, institutional ethics committee and any person or agency
required by law like the Drug Controller General of India to view your data, if required.
The results of clinical tests and therapy performed as part of this research may be
included in your medical record. The information from this study, if published in
scientific journals or presented at scientific meetings, will not reveal your identity.

How will your decision to not participate in the study affect you?

Your decision not to participate in this research study will not affect your medical care or
your relationship with the investigator or the institution. Your doctor will still take care of
you and you will not loose any benefits to which you are entitled.

Can you decide to stop participating in the study once you start?

The participation in this research is purely voluntary and you have the right to withdraw
from this study at any time during the course of the study without giving any reasons.
However, it is advisable that you talk to the research team prior to stopping the treatment.
You may be advised about how best to stop the treatment safely. If you withdraw, you
may be asked to undergo some additional tests to which you may or may not agree.
Though advisable that you give the investigators the reason for withdrawing, it is not
mandatory.

Can the investigator take you off the study?

You may be taken off the study without your consent if you do not follow instructions of
the investigators or the research team or if the investigator thinks that further participation
may cause you harm.

Right to new information

If the research team gets any new information during this research study that may affect
your decision to continue participating in the study, or may raise some doubts, you will be
told about that information.

68
 Annexures

Contact persons

For further information / questions, you can contact us at the following address:

Principal Investigator:

Dr.Manuj Kumar

Co-Investigator

1.Dr. R. K. Verma, Professor, Deptt. of Anaesthesiology, Dr. RPGMC Tanda.

2.Dr. Bhanu Awasthi, Professor & Head, Deptt. of Orthopaedics, Dr. RPGMC Tanda.

3.Dr. Shyam Bhandari, Assistant Professor, Deptt. of Anaesthesiology, Dr. RPGMC

Tanda.

In case of conflicts, you can contact the above persons whenever required.

Participant’s initials: ____

69
 General Information
group ASA duration of HR
Sr. No. name (SUPINE-1) Age sex(M-1/F-2) wt ht(cms) BMI Grade Diagnosis Surgery surgery(min) Baseline 5min 10min 15min 20min 25min 30min 1 hour Baseline 5min 10min
1 sumna 1 42 2 60 162 24.03 1 #BB rt leg distal 1/3rd interlocking nail 73 74 74 62 58 74 79 76 70 109 146 143
2 kailasho 1 40 2 65 162 24.76 1 open #shaft tibia rt nailing 90 93 92 87 82 104 62 56 58 112 126 120
3 purshtam 1 65 1 55 165 20.23 1 # BB lt leg ORIF n plating 65 63 65 69 68 61 83 82 78 114 114 122
4 vicky 1 27 1 60 155 24.97 1 # BB rt leg external fixator 70 78 81 76 70 86 91 80 80 134 132 132
5 gurmail 1 45 1 52 150 23.11 1 # BB lt leg CRIF n IMN 70 76 71 67 66 64 86 82 80 127 112 135
6 sanjela 1 62 2 50 155 20.82 2 p/o/c/o tkr with dischage rt debridment 70 106 96 92 101 96 62 58 65 140 132 126
7 ashwani 1 24 1 55 154 23.19 1 OPEN #TIBIA midshaft lt ORIF 65 87 84 83 74 86 90 80 74 116 124 124
8 prabhat 1 50 1 50 150 22.22 1 open # BB rt leg external fixator 102 125 120 114 72 78 87 79 72 132 130 127
9 nisha 1 35 2 57 153 24.34 1 open # proximal tibia lt nailing 122 82 78 81 80 80 84 91 90 142 163 160
10 praveen 1 27 1 54 152 23.37 1 open # proximal phalynx lt ORIF 70 96 91 87 83 87 89 81 80 114 153 143
11 sunny 1 20 1 55 160 21.48 1 # bimalleolar ankle rt external fixator 60 66 76 84 66 70 82 87 72 132 115 118
12 shikha 1 35 2 60 154 25.29 1 # bimalleolar ankle lt ORIF n plating 80 91 84 91 72 71 82 88 85 117 109 110
13 sitaram 1 55 1 60 155 24.97 1 # BB lt leg ORIF n plating 65 89 84 94 111 82 76 81 93 121 103 130
14 bhajan 1 28 1 55 163 20.07 1 # proximal BB RT CRIF n hybrid fixator 75 68 72 68 68 70 74 87 87 113 110 109
15 munish 1 34 1 60 156 24.65 1 # proximal tibia rt nailing 105 81 69 84 90 101 72 65 68 115 116 117
16 amit 1 31 1 62 159 24.52 1 #BB lt leg ORIF n plating 85 87 93 96 108 87 74 78 76 143 140 136
17 surjit 1 35 1 55 162 20.96 1 # proximal tibia lt CRIF n ILN 100 108 98 96 94 88 78 84 74 124 124 115
18 Sulochna 1 62 2 60 160 23.43 2 # BB distal 1/4 rt leg ORIF n plating 105 79 80 70 71 70 80 78 89 126 112 107
19 ram 1 35 1 59 167 21.15 1 #rt ankle ORIF with PTCS 102 84 82 87 86 98 76 67 76 112 112 112
20 manish 1 22 1 55 166 19.95 1 open# rt tibia ORIF with tibia nailing 100 87 84 88 84 80 84 76 72 120 138 125
21 jalon 1 55 1 66 167 23.66 1 # open lt tibia ORIF with IMLN 101 78 87 80 80 84 78 78 70 124 112 120
22 munish 1 34 1 60 162 23.86 1 # proximal tibia rt side ORIF 95 88 78 90 78 78 86 89 84 134 116 118
23 amit 1 31 1 67 170 23.18 1 #BB lt leg ORIF 90 90 66 94 70 80 81 85 81 136 124 123
24 surjit 1 35 1 64 164 23.79 1 3 proximal tibia lt CRIF with ILN 100 98 67 76 70 80 80 79 67 142 112 112
25 bhagwan 1 56 1 74 176 23.88 2 OA rt knee TKR rt side 95 78 90 78 74 78 80 74 72 132 128 124
26 vinod 1 26 1 65 167 23.44 1 # bicondylar rt tibia ORIF with PTCS 126 76 70 80 78 80 78 78 80 123 134 112
27 AMIT 1 28 1 60 163 22.58 1 #lateral condyle lt tibia ORIF 90 70 78 80 86 80 87 76 80 114 132 128
28 Pooja 1 32 2 70 171 23.93 1 #tibia lt ORIF n plating 80 72 78 78 80 78 76 78 76 112 132 126
29 ashok 1 50 1 66 163 24.84 2 OA lt knee lt TKR 102 74 88 80 68 80 82 86 76 142 126 130
30 Sworop 1 40 1 61 160 23.83 1 # lateral condyle tibia lt ORIF with plating 105 67 87 90 85 80 78 78 79 126 112 134
 INTRAOPERATIVE PARAMETERS
SBP DBP MAP
15min 20min 25min 30min 1 hour Baseline 5min 10min 15min 20min 25min 30min 1hour Baseline 5min 10min 15min 20min 25min 30min 1 hour atro(Y-1/N-2)
139 150 113 112 112 68 89 79 72 81 92 68 64 81.67 92 91 94 109 137 76 75 2
145 145 106 106 110 78 78 86 68 71 65 78 72 89.33 71 71 71 78 76 86 86 2
107 119 129 146 132 78 76 78 70 74 89 87 80 90 88 92.66666667 82 89 109 117 116 2
120 120 136 104 112 85 73 73 78 68 83 82 78 101 92 92 85 85 100 80 80 2
112 112 110 106 108 67 87 78 69 67 56 69 72 87 95.33333333 76 83.33333333 77 74 80 80 2
129 126 109 177 139 83 90 89 90 94 60 87 80 102 104 101 110 104 76.33333333 128 96 2
136 139 106 179 146 80 76 74 88 88 62 82 77 92 92 90 104 105 76.66666667 145 95 2
105 114 106 132 124 83 80 72 82 86 58 70 72 99 96 90 74 95.33333333 74 90 90 2
160 149 136 136 122 90 97 96 96 91 88 86 80 115 119 117 117 110 104 102 102 2
141 126 104 154 142 88 81 80 75 96 78 70 72 108 105 101 97 106 86.66666667 145 99 2
127 133 112 110 106 80 79 77 79 80 68 70 74 97 91 90 95 97 89 85 86 2
102 134 112 109 109 73 71 76 65 78 65 69 72 87 83 87 77 71 80.66666667 88 88 2
134 122 124 150 142 73 78 78 87 56 78 83 80 89 77 95.33333333 54 78 63 105 95 2
108 123 106 124 118 69 72 73 80 66 72 78 70 83 84 85 79 78 83 93 94 2
108 118 116 131 124 75 72 78 79 82 78 72 70 88 86 91 88 94 90.66666667 91 92 2
117 112 122 112 109 78 81 82 75 76 72 83 80 99 100 100 89 88 88.66666667 92.67 90 2
110 126 110 106 106 76 77 73 70 68 78 76 70 92 92 87 83 87.33333333 88.66666667 76 76 2
130 114 134 110 112 97 81 72 75 69 70 69 68 111 91 83 84 80 91.33333333 79 70 2
126 126 135 120 120 84 87 78 80 76 76 70 74 93.33 93.33 89.33 95.33 92.67 95.66666667 86.67 86 2
120 124 130 122 112 80 89 89 80 67 75 70 72 93.33 99.33 101 93.33 86 93.33333333 87.33 88 2
127 126 122 121 124 78 89 90 87 78 90 88 80 93.33 93.33 100 100.33 94 100.6666667 99 100 2
125 112 120 124 125 77 80 92 70 70 78 90 79 96 90 86 88.33 84 92 101.33 101 2
134 134 117 123 120 87 89 69 70 90 76 78 78 103.33 100.67 87 91.33 104.67 89.66666667 93 94 2
136 125 114 134 130 80 78 78 87 80 79 89 78 100.67 89.33 89.33 103.33 95 90.66666667 104 105 2
112 134 120 133 130 82 78 70 75 89 90 90 85 98.67 94.67 88 87.33 104 100 104.33 104 2
135 125 121 132 132 88 76 72 74 98 84 94 89 99.67 95.33 85.33 95 107 96.33333333 106.67 106 2
142 127 122 150 138 85 70 74 87 90 82 87 82 94.67 90.67 92 105.33 102.33 95.33333333 108 108 2
112 124 126 124 136 76 70 84 74 78 83 86 80 88 90.67 98.67 86.67 94.33 97.33333333 98.67 98 2
135 125 125 128 124 77 76 80 70 76 78 84 76 98.67 92.67 96.67 91.67 92.33 93.66666667 98.67 98 2
116 115 116 132 132 89 84 80 78 74 76 78 74 101.33 93.33 98 90.67 87.67 89.33333333 96 96 2
 INTRA-OP(HR,MAP)
supine up (pinprick loss) supine down( pinprick loss) motor block -up motor block down
EPHEDRINE OXYGEN onset(s) max.lev(S) T-level seg's.block 2seg reg duration onset(S) max.lev(S) T-LEVEL seg's.block 2 seg reg duration onset(S) duration onset(S) duration HR-1hr HR-2 hr MAP-1 hr
2 2 170 360 9 3 65 145 140 350 7 5 80 150 290 55 300 70 76 86
2 2 130 300 6 6 55 110 120 290 5 7 65 125 250 45 250 95 89 82
2 2 180 360 8 4 60 145 170 300 6 6 70 155 220 70 250 75 87 90
2 2 140 400 8 4 75 100 120 360 8 4 90 120 310 75 300 80 80 84
2 2 110 300 5 7 50 130 100 300 6 6 65 135 350 70 350 85 90 95
2 2 220 300 6 6 60 75 200 300 8 4 65 100 400 65 330 95 84 84
2 2 100 420 6 6 80 90 90 360 8 4 85 110 300 70 320 80 78 88
2 2 70 470 6 6 70 135 60 460 6 6 75 140 420 85 420 95 70 80
2 2 110 430 6 6 55 80 100 300 8 4 70 115 460 75 380 70 71 75 94
2 2 180 310 8 4 70 120 60 300 6 6 75 135 350 75 300 75 69 91
2 2 110 360 8 4 45 125 70 360 8 4 55 135 290 55 320 85 80 90
2 2 50 310 6 6 70 130 60 360 8 4 80 145 340 75 370 80 84 81
2 2 120 360 5 7 60 140 100 240 6 6 65 160 400 65 360 70 87 94
2 2 110 360 8 4 65 110 100 350 8 4 70 130 390 85 360 85 80 80
2 2 220 350 8 4 60 90 140 360 8 4 70 115 310 65 340 75 78 84
2 2 190 340 6 6 55 105 70 310 8 4 70 120 320 70 250 70 78 72
2 2 180 290 8 4 60 90 80 300 6 6 65 95 300 55 300 85 73 89
2 2 130 310 8 4 65 80 90 300 6 6 75 105 370 75 360 85 69 84
2 2 120 290 7 5 55 105 110 300 6 6 65 115 430 80 280 80 90 87
2 2 190 300 8 4 65 85 160 300 8 4 70 105 260 95 270 95 82 85
2 2 190 370 6 6 70 115 140 320 6 6 80 130 210 55 300 85 75 90
2 2 130 360 8 4 60 110 120 300 8 4 70 115 250 80 250 80 79 95
2 2 230 240 6 6 50 95 200 250 4 8 60 100 200 55 190 95 72 87
2 2 180 300 9 3 70 105 160 400 8 4 75 115 280 70 300 45 74 89
2 2 190 310 6 6 60 85 150 290 8 4 70 105 240 70 170 75 70 93
2 2 280 450 8 4 45 75 230 300 6 6 70 105 300 80 300 90 80 82 91
2 2 170 240 8 4 75 130 120 300 6 6 85 145 180 70 160 65 82 92
2 2 280 320 8 4 75 125 260 290 6 6 80 140 240 90 240 90 76 82
2 2 140 250 8 4 70 110 120 250 8 4 80 125 380 70 370 70 78 90
2 2 200 340 8 4 60 105 130 300 6 6 65 110 310 55 240 85 71 84
 POST OP PARAMETERS
total duration
MAP-2 hr of analgesia HR SBP DBP MAP SPO2
165 84 121 82 95 100
174 96 105 90 95 100
168 92 120 76 91 100
156 90 116 78 91 100
163 68 108 73 85 100
153 90 109 82 91 100
170 99 125 77 93 100
176 92 126 90 102 99
90 169 92 118 65 83 100
166 76 112 63 79 99
164 98 108 79 88.65 100
158 98 122 80 94 100
159 82 101 65 77 100
155 61 109 70 83 100
149 98 118 84 95.33 100
167 106 114 77 89 100
173 84 112 74 87 100
159 70 120 74 89 100
169 78 124 70 88 100
163 76 122 76 91 100
170 85 112 79 90 100
169 80 126 73 91 98
173 80 122 73 89 99
169 70 120 72 89 98
166 72 125 80 95 97
84 170 71 122 70 94 100
175 70 112 69 83 100
168 70 110 72 85 100
167 84 108 78 88 100
159 80 126 80 95 100
 General Information INTRA OPERATIVE
PARAMETERS HR
Sr. No. Name Age sex(M-1/F-2) wt ht(cm) BMI ASA Grade Diagnosis Surgery Dur. Of surgery(MIN) Baseline 5min 10min 15min 20min 25min 30min 1 hour
1 suman 2 42 1 54 156 22.18 1 # LT tibia distal 1/3rd ORIF with IMLN 70 69 68 65 75 78 76 78 72
2 Sumna 2 42 2 62 158 26.63 1 # BB RT distal 1/3rd tibia ORIF with IMLN 80 100 100 98 96 97 71 76 70
3 Sita Ram 2 55 1 51 159 20.17 2 # BB lt leg ORIF with IMLN 65 79 83 78 69 76 74 68 74
4 rakesh 2 60 1 67 161 25.84 1 # BB lt leg CRIF with PFN 50 103 84 85 107 76 86 86 81
5 Kiran 2 35 2 52 157 21.09 1 #BB left leg ORIF with Plating 60 64 64 60 68 62 87 88 80
6 pritam 2 35 1 54 162 20.57 1 Bimalleolar # lt leg ORIF with TBW 60 45 44 53 59 65 84 98 90
7 Kishori 2 58 1 52 157 21.1 2 #Bimalleolar lt ankle ORIF with TBW 55 110 89 82 84 86 90 87 80
8 sushil 2 41 1 68 163 25.59 1 open # BB rt leg exchange nailing 70 92 67 75 63 59 96 65 66
9 mohit 2 36 1 67 155 27.88 1 Rt BB # ORIF 85 107 118 97 79 63 63 56 72
10 Sonu 2 27 2 57 161 21.98 2 # BB lt leg without DNVD CRIF with PFN 75 61 60 74 61 86 71 56 65
11 Amit 2 33 1 64 158 25.63 1 Segmental open # tibia lt ORIF with nailing 70 93 84 83 86 85 82 87 80
12 surjeet 2 45 1 62 152 26.83 1 # proximal rt tibia ORIF with plating 50 108 96 91 87 76 64 78 70
13 vijay 2 52 1 66 163 24.84 1 # distal end of tibia lt ORIF with Plating 45 112 97 92 81 78 69 76 78
14 ardesh 2 19 2 55 165 20.26 1 open # patella rt ORIF with TBW 80 88 84 83 88 85 81 67 60
15 Mohindr 2 36 1 53 158 21.23 2 #BB rt leg ORIF with IMLN 70 68 67 72 61 91 88 87 88
16 ayub 2 45 1 61 158 24.43 1 # lateral condyle rt tibia ORIF with Plating 101 112 117 99 96 61 62 64 64
17 kuldeep 2 48 1 54 161 20.83 1 # Tibia rt ORIF with Plating 121 68 66 70 62 57 78 90 89
18 sharda 2 45 2 55 154 23.19 1 # bimalleolar rt leg ORIF with Plating 60 79 81 76 74 72 76 96 90
19 Brahmi 2 50 2 57 163 21.45 1 # BB RT leg ORIF with ILN 105 51 48 44 52 58 66 89 84
20 shanker 2 60 1 59 153 25.26 2 Segmental open # tibia lt ORIF with Plating 55 66 68 71 69 62 86 88 80
21 jitender 2 55 1 65 157 26.37 1 P/O/C/O # BB Rt leg transtibial amputation 45 108 96 94 106 68 68 87 80
22 hanif 2 50 1 56 159 22.15 2 open# BB rt leg debridment,ext.fixator 65 81 82 79 67 76 88 78 76
23 Ashinder 2 38 1 58 157 23.53 1 # proximal rt tibia ORIF with Plating 107 99 102 97 96 97 74 87 82
24 sunil 2 22 1 62 158 24.83 1 open # BB LT leg ORIF n plating 70 68 70 68 74 79 77 80 78
25 omkar 2 40 1 60 159 23.73 1 Communited #BB LT leg I and D ,Ext fixator 75 73 78 74 66 64 56 70 72
26 sumit 2 32 1 66 154 27.82 2 Open # lt patella ORIF with K wire 95 96 91 76 68 66 85 89 81
27 akshay 2 24 1 55 159 21.75 1 # BB LT leg ORIF with Plating 60 76 77 64 58 54 78 87 80
28 pankaj 2 31 1 60 159 23.73 1 # open BB lt leg ORIF with ext.fixator 40 86 81 88 72 71 78 68 65
29 mehar 2 60 1 54 164 20.07 1 Rt BB # ORIF 90 106 96 66 64 56 76 67 62
30 bharam 2 56 1 52 166 18.87 2 # BB RT leg ORIF with nailing 130 78 69 66 67 86 76 64 60
 SBP DBP MAP
Baseline 5min 10min 15min 20min 25min 30min 1 hour Baseline 5min 10min 15min 20min 25min 30min 1 hour Baseline 5min 10min 15min 20min 25min
143 148 144 157 162 143 103 100 86 85 82 96 99 92 87 80 105 106 102.6666667 116.3333333 120 109
124 124 112 112 107 107 106 105 76 76 71 71 64 64 82 80 92 92 84.66666667 84.66666667 78.33333333 78.33333333
146 160 178 156 126 112 106 100 94 96 98 94 90 89 80 70 111.3333333 117.3333333 124.6666667 114.6666667 102 96.66666667
119 123 116 138 126 116 112 110 64 70 84 91 88 68 78 70 82.33333333 87.66666667 94.66666667 106.6666667 100.6666667 84
164 176 139 106 116 124 120 112 91 90 73 87 60 78 76 71 115.3333333 118.6666667 95 93.33333333 78.66666667 93.33333333
120 116 112 111 116 140 122 128 73 70 72 68 71 84 76 72 88.66666667 85.33333333 85.33333333 82.33333333 86 102.6666667
121 112 110 112 100 146 124 120 68 56 72 74 78 74 78 78 85.66666667 74.66666667 84.66666667 86.66666667 85.33333333 98
129 117 108 110 136 126 122 118 74 70 63 70 76 86 78 76 92.33333333 85.66666667 78 83.33333333 96 99.33333333
111 110 101 106 134 126 124 122 76 69 73 80 82 65 90 80 87.66666667 82.66666667 82.33333333 88.66666667 99.33333333 85.33333333
127 140 140 127 140 141 126 128 69 82 76 82 90 73 92 90 88.33333333 101.3333333 97.33333333 97 106.6666667 95.66666667
127 126 122 126 124 133 112 110 80 70 74 86 63 73 87 84 95.66666667 88.66666667 90 99.33333333 83.33333333 93
126 133 114 104 126 122 120 134 74 70 68 72 75 68 82 80 91.33333333 91 83.33333333 82.66666667 92 86
132 152 163 119 122 126 124 122 99 74 74 72 76 74 78 75 110 100 103.6666667 87.66666667 91.33333333 91.33333333
128 126 123 127 124 130 126 119 84 77 73 80 63 77 76 72 98.66666667 93.33333333 89.66666667 95.66666667 83.33333333 94.66666667
129 136 140 133 136 140 128 122 77 84 81 74 96 76 74 70 94.33333333 101.3333333 100.6666667 93.66666667 109.3333333 97.33333333
136 126 109 112 124 122 140 135 94 79 74 76 78 70 85 80 108 94.66666667 85.66666667 88 93.33333333 87.33333333
127 119 107 124 122 134 142 144 69 70 84 80 78 68 68 69 88.33333333 86.33333333 91.66666667 94.66666667 92.66666667 90
135 133 102 112 120 136 130 128 84 76 80 78 80 84 90 80 101 95 87.33333333 89.33333333 93.33333333 101.3333333
123 120 104 106 118 112 132 129 74 66 82 88 82 82 92 84 90.33333333 84 89.33333333 94 94 92
166 176 140 108 122 126 132 130 86 88 90 83 84 69 89 85 112.6666667 114 118.6666667 102 92 86.66666667
121 124 118 133 124 146 120 117 90 66 76 74 70 74 84 80 100.3333333 84.33333333 92 88.66666667 91 90.66666667
154 162 177 158 128 165 122 120 92 96 94 94 90 78 88 84 112.6666667 115.3333333 116.6666667 121.6666667 112.6666667 94.66666667
126 126 114 106 112 104 124 117 68 77 76 78 72 68 86 80 87.33333333 93.33333333 92.66666667 90 83.33333333 82.66666667
144 147 143 158 146 140 124 121 74 86 85 83 94 98 78 74 97.33333333 105.3333333 105.6666667 103 115.3333333 114
118 123 108 112 112 122 122 118 65 84 86 80 80 82 79 76 82.66666667 95.33333333 98.33333333 89.33333333 90.66666667 92
144 141 124 108 108 116 126 124 68 99 86 76 80 78 90 88 93.33333333 113 114 104.3333333 92 89.33333333
112 113 104 108 112 119 126 126 76 66 70 72 78 82 92 90 88 81.67 81.33333333 84.33333333 82.66666667 88
136 127 123 108 110 120 112 122 80 84 81 82 78 68 84 80 98.66666667 98.33 101.3333333 96.33333333 95.66666667 88
118 114 116 110 106 114 122 127 92 66 76 84 82 68 82 80 100.6666667 82 83.33333333 88.66666667 94.66666667 91.33333333
118 112 120 112 128 126 128 123 82 84 72 70 88 68 86 84 94 93.33 95.33333333 85.33333333 86.66666667 96
 SENSORY AND MOTOR ASSESMENT
head up group-up (pinprick loss) head up group-down (pinprick loss) motor block up motor block- down HR-1HR HR-2 HR
30min ATROPINE ephedrine OXYGEN onset(S) max.level(S) T-level seg's block 2 seg reg duration onset(S) max.level(S) T-level seg's block 2 seg reg duration onset(S) duration onset(M) duration
92.33 90 2 2 2 170 360 9 3 90 155 160 320 7 5 100 170 300 105 250 90 84
90 89 2 2 2 190 480 8 4 75 105 150 460 8 4 85 130 230 100 350 95 96
88.67 84 2 2 2 230 460 9 3 90 155 200 430 7 5 95 170 290 55 350 105 78
89.33 86 2 2 2 120 420 8 4 80 105 100 350 8 4 90 120 190 75 340 90 72
90.68 91 2 2 2 100 360 9 3 90 150 90 310 7 5 100 155 280 90 190 75 65
91.33 90 2 2 2 180 300 8 4 60 145 180 280 8 4 70 150 230 60 270 95 68
93.33 89 2 2 2 190 250 6 6 70 140 180 200 9 3 75 155 220 75 310 70 74
92.67 90 2 2 2 240 430 8 4 75 135 200 400 9 3 90 145 190 60 320 75 76
101.33 100 2 2 2 180 480 8 4 70 145 170 430 6 6 70 150 160 100 310 70 78
103.33 98 2 2 2 70 470 9 3 85 165 100 420 7 5 90 170 230 65 240 100 80
95.33 91 2 2 2 230 340 8 4 75 95 210 350 9 3 90 115 310 95 320 75 84
94.67 90 2 2 2 170 480 9 3 95 140 150 360 8 4 95 145 190 80 300 95 82
93.33 89 2 2 2 140 310 8 4 90 140 100 280 9 3 95 145 350 85 320 85 78
92.67 91 2 2 2 150 300 9 3 85 130 140 300 9 3 90 145 280 85 340 95 71
92 90 2 2 2 120 350 8 4 65 90 100 340 6 6 75 155 430 65 320 70 69
103.33 98 2 2 2 100 400 9 3 85 145 90 410 8 4 90 160 320 70 170 90 70
92.67 90 2 2 2 90 350 8 4 80 105 60 300 9 3 90 135 230 60 310 70 76 70
103.33 91 2 2 2 180 260 6 6 70 125 180 240 6 6 90 145 320 70 190 85 65
105.33 100 2 2 2 240 340 8 4 60 130 150 300 9 3 75 140 460 85 320 80 87
103.33 89 2 2 2 190 410 7 5 65 125 160 360 8 4 65 135 330 60 340 80 91
104.6666667 99 2 2 2 240 500 9 3 85 145 200 460 9 3 90 165 500 70 300 95 90
113.6666667 98 2 2 2 170 320 7 5 45 95 150 400 8 4 60 105 320 85 280 95 87
92 91 2 2 2 180 350 9 3 90 155 90 340 9 3 100 160 460 50 230 80 80
98.66666667 93 2 2 2 240 600 7 5 65 90 230 420 8 4 70 95 270 65 360 75 74
93.33333333 90 2 2 2 180 300 9 3 95 115 120 300 9 3 95 140 250 60 120 90 76
88 87 2 2 2 240 340 9 3 90 140 180 240 6 6 95 145 220 60 260 80 73
92 90 2 2 2 190 260 9 3 90 125 160 200 8 4 100 145 250 85 270 100 70
82 82 2 2 2 120 340 9 3 90 120 100 300 9 3 100 140 190 55 190 85 87
80.66666667 78 2 2 2 190 400 6 6 50 90 90 240 9 3 60 130 450 95 190 105 82
88 84 2 2 2 80 180 9 3 90 155 100 170 8 4 95 160 240 95 330 75 80 84
INTTRA-OP (HR, MAP) total duration POST OP PARAMETERS
MAP-1HR MAP-2 HR of analgesia HR SBP DBP MAP SP02
95 99
104 180 84 105 90 95 100
101 189 76 120 76 91 98
91 194 87 116 78 91 100
92 169 67 108 73 85 98
90 185 80 109 82 91 99
91 188 72 125 77 93 97
95 178 70 124 90 102 96
102 170 70 118 65 83 99
99 192 72 112 64 79 100
95 195 88 108 79 88 99
102 171 104 122 80 94 98
104 172 94 101 65 77 98
94 178 76 110 70 83 98
84 170 87 118 84 95 95
87 181 76 115 77 89 98
78 184 84 110 74 87 97
93 90 189 65 120 74 89 98
89 193 87 124 70 88 93
86 192 59 122 76 91 90
78 176 90 112 79 90 99
98 172 67 112 69 83 99
94 175 78 110 72 85 99
90 183 92 108 78 88 97
91 178 56 101 65 77 97
86 180 78 118 65 83 98
83 175 75 109 73 85 99
79 166 84 120 75 89 98
84 169 89 113 69 83 96
90 181 94 110 73 85 95
93 86 179 84 106 70 84 76