Covering Letter for Reasearch Protocol

The Controller,
Research and Training Monitoring Cell,
College of Physician and Surgeon, Pakistan
Respected sir,
Enclosed herewith the copy of synopsis titled:
Comparison of the mean duration of sensory blockade with bupivacaine and
bupivacaine plus dexamethasone combination in patients undergoing
orthopedic procedures under spinal anesthesia.
DURATION OF STUDY: The study will start after the approval of synopsis.
Study period is six months.
Prepared by:
As a pre-requisite for FCPS II in
Copy submitted on:
RTMC Registration Number:
FCPS Roll No
Session:
Trainee Signature:
Name of Supervisor
Name of training Institution:
Department:

Dr. Aqeel Ahmad

Anesthesiology
October, 2015
ANS-2014-055-1356
35001
20-11-2012
Dr. Muhammad Ashraf Zia
Jinnah Hospital, Lahore
Anesthesia/ICU

Supervisor:
Dr. Muhammad Ashraf Zia
MCPS, FCPS.
Head Of Department
Associate Professor Department of
Anesthesia
Jinnah Hospital Lahore.

Comparison of the mean duration of

sensory blockade with bupivacaine and
bupivacaine plus dexamethasone
combination in patients undergoing
orthopedic procedures under spinal
anesthesia.
By
Dr. Aqeel Ahmad
POST GRADUATE TRAINEE
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE

Supervisor
Dr. M. ASHRAF ZIA
MCPS, FCPS
ASSOCIATE PROFESSOR & HEAD OF DEPARTMENT
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE
ALLAMA IQBAL MEDICAL COLLEGE,

JINNAH HOSPITAL LAHORE

Introduction
Regional anesthesia is preferred for any type of surgery whenever
possible over general anesthesia. Among neuraxial blocks, Spinal
anesthesia is widely used for orthopedic surgeries, cesarean section
and even laparoscopic cholecystectomy is being done in spinal
anesthesia(1). Regional techniques can even control pain from several
hours to several days, depending upon the type of local anesthetic
agent, adjuvant and technique used. Initial pain management may
reduce subsequent pain in the days to weeks following surgery.
Regional anesthesia is associated with lesser morbidity and has
decreased chances of deep vein thrombosis. Greater reduction in pain
makes the possibility of earlier hospital discharge and may improve the
patient's ability to tolerate physical therapy(2). Different adjuvant like
opioids, steroid, ketamine, dexmedetomidine have been used to
improve the quality and prolong the effect of the local anesthetic
action in different peripheral nerves and regional block techniques (3).
Dexamethasone is the most commonly prescribed corticosteroid for
pain. Dexamethasone has also been used as an adjuvant for spinal
anesthesia(4).

Dexamethasone has been shown to possess anti-

inflammatory action in addition to increasing the duration of local

anesthetics action.(5) It also decreases the need of post-operative
opioid requirement when used as adjuvant with local anesthetics in

peripheral neural blocks.(6, 7) Nadia Bani-hashem and at al conducted

a study showing that the addition of dexamethasone to bupivacaine
increases the duration of sensory blockade in spinal anesthesia without
complications. The duration of the sensory blockade was 119.110.6
minutes in the case group and 89.48.3 minutes in the control group
with a P value less than 0.001; also pain-free period in the case group
was more than that in the control group(P<0.001).(8)
Rational of my study is to find the effect of addition of
dexamethasone to bupivacaine in spinal anesthesia for orthopedic
procedures. There are very few studies which tried to discover the
outcome of stated combination. There are no local studies available. It
will be cost effective and decrease the requirement of post- op
analgesics if study is proven right.

OBJECTIVE:
To compare the mean duration of sensory blockade with bupivacaine
and

bupivacaine

plus

dexamethasone

combination

in

undergoing orthopedic procedures under spinal anesthesia.

OPERATIONAL DEFINATION:
MEAN DURATION:

patients

It is the average time taken in minutes after peak of sensory block up

to 4 sensory level regressions or when VAS (Annexure I) score
exceeded 3 at surgical site.

SENSORY BLOCKADE:
It is the complete loss of feelings of temperature, touch and pain
(pinch) when checked in midaxillary line bilaterally.

HYPOTHESIS:
Bupivacaine plus dexamethasone combination has prolonged mean
duration of spinal anesthesia in patients as compared to bupivacaine
alone.

MATERIAL AND METHOD:

Study Design: Randomized Control trial
Study Setting: Orthopedic operation theatre, Jinnah hospital Lahore
Duration of Study: Six months after approval of synopsis
Sampling technique: Non probability purposive sampling.
Sample size: Sample size of 40 cases, 20 in each group is calculated
with 99% confidence level and 95% power of test and taking duration
of

sensory

blockade

11910.69

minutes

with

bupivacaine

dexamethasone combination and 89.448.37 minutes in bupivacaine

alone.

SAMPLE SELECTION:
Inclusion Criteria:
1. Patients with status ASA I & II (Annexure II)
2. Age 18-70 years
3. Patients going for elective orthopedic procedures on pelvis,
femur, tibia and ankle.

Exclusion Criteria:
1.
2.
3.
4.

Refusal of patient to give informed consent

Pre-existing coagulation disorder
Morbid obesity
Local infection
5. Diabetes Mellitus

Data Collection Procedure:

After taking approval from ethical committee and taking informed consent, 40
patients fulfilling the selection criteria will be selected for the study from
operation theatres of Jinnah Hospital, Lahore. After taking informed consent,
demographic information like name, age, sex, height, weight and contact will
be obtained. Then patients will be divided into two groups by using lottery
method. . After IV line preparation, a 10 ml per kg lactated ringers solution
will be given to all patients as preload. Patients will receive no premedication,
and patients after reaching to the operating room will be monitored with
ECG, peripheral oxygen saturation (SPO2), and noninvasive arterial blood
pressure (NIBP) and will be recorded at 5-minute intervals until the end of

surgery and vital signs will recorded every 15 minutes in the Post Anesthesia
Care Unit (PACU). Spinal anesthesia will be performed in the sitting position at
L3L4 or L4-L5 level through a midline approach using a 23-25 gauge Quincke
spinal needle. Patients of the group B will receive 15 mg (2 ml) of 0.75%
hyperbaric bupivacaine diluted in preservative free normal saline (2 ml) and
patients of the group D will receive 15 mg (2 ml) of 0.75% hyperbaric
bupivacaine and 8 mg preservative free dexamethasone 4 ml ntrathecally.
After performance of the spinal anesthesia patients will be kept in supine
position and oxygen 3-5 L per min will be given through a face mask. The
sensory block level will be assessed by pin prick test with a short bevel
needle along the mid-axillary line bilaterally. The sensory block level will be
evaluated every 5 minutes after one hour until a 4 sensory level regression
from highest level or to the end of the surgery. Hypotension, a 30% decrease
in systolic blood pressure from base line or systolic blood pressure <90 mm
Hg and bradycardia, HR<50 beats/min will be treated by IV adrenaline 5-10
microgram plus crystalloid fluids; and IV atropine 0.5 mg respectively. Nausea
and vomiting will also be evaluated and will be treated with 0.15 mg /kg IV
metoclopramide. After 4 dermatome block regression, pain assessment
intraoperatively or in PACU will be done using the visual analogue pain scale
(VAS) between 0-10 (0 = no pain, 10 = the most severe pain) every 1 hour. If
the postoperative VAS was higher than 6, it will be treated by nalbuphine 2
mg IV. Patients will be observed at time of discharge from hospital and 1
month later will be questioned about any neurologic deficit. The primary
outcome will be duration of sensory blockade of spinal anesthesia, as
evaluated by VAS for pain scoring at interval of 5 minutes postoperatively.
The secondary outcomes will be time required for first analgesia (TFA),
analgesic

consumption

and

the

occurrence

of

nausea,

vomiting

or

somnolence. Furthermore, any suspected adverse drug reactions will be

noted. The patients will be instructed preoperatively about the use of the VAS
for pain assessment on a 10-cm line (VAS; 0=no pain, 10=worst pain
imaginable).

Data Analysis:
The data will be entered and analyzed in SPSS version 17.0. Quantitative
variables like age and BMI will be measured in the form of mean SD.
Qualitative variables like gender and status will be measured in the form of
frequency and percentages. Both groups will be compared by using
independent sample t-test taking p-value < 0.01 as significant. Data will be
stratified for BMI.

ANNEXURE I:

VISUAL ANALOGUE SCALE (VAS)

1. This diagram will be printed on a sheet to ensure that these are exactly 10cm in length
2. The print out will be folded at the dotted line.
3. Patient is not shown the numbered side and asked to mark the line according to her
pain by moving from no pain to worst pain.
4. VAS score will be measured by unfolding the numbered side and recording the
corresponding score.

ANNEXURE II
Classification of American Society of
Anesthesiologists (ASA Classification)
ASA I: A normal healthy patient
ASA II: A patient with mild systemic disease (No functional
limitation)
ASA III: A patient with severe systemic disease (some functional
limitation)
ASA IV: A patient with severe systemic disease (functionally
incapacitated)
ASA V: A moribund patient who is not expected to survive without
the operation.
ASA VI: A brain dead patient whose organs are being donated for
donor purposes.
E: When the procedure is an emergency.

PERFORMA:
Comparison of the mean duration of sensory blockade with bupivacaine and
bupivacaine plus dexamethasone combination in patients undergoing
orthopedic procedures under spinal anesthesia

Patients name: ..........................

Group: .....................................

Age/Sex: ........................................

Date: .........................................

Hospital Record No: ...............

Weight in kg: ............................

Time for First Analgesia.

Total Analgesic consumption in 24 hours post-op .
Time in minutes

VAS Score/

Time in minutes

Regression level

70
75
80
85
90
95
100
110

VAS Score/
Regression level

115
120
125
130
135
140
145
150

References
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Imbelloni LE. Spinal anesthesia for laparoscopic cholecystectomy:

Thoracic vs. Lumbar Technique. Saudi Journal of Anaesthesia.

2014;8(4):477-83.
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Guay J, Choi P, Suresh S, Albert N, Kopp S, Pace NL. Neuraxial

blockade for the prevention of postoperative mortality and major

morbidity: an overview of Cochrane systematic reviews. The Cochrane
database of systematic reviews. 2014;1:Cd010108.
3.

Abdel-Aleem M, Osman A, Morsy K. Effect of coadministration of

dexamethasone with intrathecal morphine on postoperative outcomes

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Naziri F, Rabiee SM, Banihashem N, Hosseinjanzadeh K, Shirkhani

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7.

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