Download Kempegowda Institute of Medical Sciences

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
SYNOPSIS OF DISSERTATION
“ A COMPARATIVE STUDY OF INTRATHECAL HYPERBARIC
BUPIVACAINE 0.5% WITH FENTANYL VERSUS HYPERBARIC
BUPIVACAINE 0.5% WITH BUPRENORPHINE IN ELECTIVE
LOWER ABDOMINAL SURGERIES IN ADULTS”
Submitted by
Dr.NAMRATHA.L
POST GRADUATE STUDENT IN
ANAESTHESIOLOGY
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE
Kempegowda Institute of Medical Sciences,
Bangalore 560004.
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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,
KARNATAKA
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
Dr. NAMRATHA . L
1
NAME OF THE CANDIDATE
AND ADDRESS
# 1178/6, 14th MAIN
PRAKASHNAGAR
BANGALORE -560021
2.
NAME OF THE INSTITUTION
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES
BANGALORE 560004.
3.
COURSE OF STUDY AND SUBJECT
M.D IN ANAESTHESIOLOGY
4.
DATE OF ADMISSION TO COURSE
3rd JUNE 2013
5.
TITLE OF THE TOPIC
6.
BRIEF RESUME OF INTENDED WORK
7
8.
A COMPARATIVE STUDY OF INTRATHECAL
HYPERBARIC BUPIVACAINE 0.5% WITH FENTANYL
VERSUS HYPERBARIC BUPIVACAINE 0.5% WITH
BUPRENORPHINE IN ELECTIVE LOWER ABDOMINAL
SURGERIES IN ADULTS.
6.1 NEED FOR THE STUDY
Enclosed
6.2 REVIEW OF LITERATURE
Enclosed
6.3 OBJECTIVES OF THE STUDY
Enclosed
MATERIALS AND METHODS
7.1 SOURCE OF DATA
7.2 METHOD OF COLLECTION OF DATA :
7.3 DOES THE STUDY REQUIRE ANY
INVESTIGATION OR INTERVENTIONS TO
BE CONDUCTED ON PATIENTS OR
OTHER ANIMALS, IF SO PLEASE
DESCRIBE BRIEFLY.
7.4 HAS ETHICAL CLEARENCE BEEN
OBTAINED FROM YOUR INSTITUTION IN
CASE OF 7.3
LIST OF REFERENCES
Enclosed
Enclosed
Yes
Yes
Enclosed
2
9.
SIGNATURE OF THE CANDIDATE
Dr.NAMRATHA.L, IS PERSUING “A
10. REMARKS OF THE GUIDE
COMPARATIVE STUDY OF INTRATHECAL
HYPERBARIC BUPIVACAINE 0.5% WITH
FENTANYL VERSUS HYPERBARIC
BUPIVACAINE 0.5% WITH BUPRENORPHINE
IN ELECTIVE LOWER ABDOMINAL SURGERIES
IN ADULTS” FOR DISSERTATION UNDER MY
GUIDANCE.
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NAME AND DESIGNATION
11.1 GUIDE
Dr. NARENDRA BABU M.C., M.D, D.A,
PROFESSOR,
DEPARTMENT OF ANESTHESIOLOGY AND
CRITICAL CARE
KEMPEGOWDA INSTITUTE OF MEDICAL
SCIENCES
BANGALORE 560004.
11.2 SIGNATURE OF THE GUIDE
11.3 HEAD OF DEPARTMENT
Dr. CHAYA. S., D.A, M.D
PROFESSOR AND HEAD OF DEPARTMENT,
DEPARTMENT OF ANESTHESIOLOGY AND
CRITICAL CARE
KEMPEGOWDA INSTITUTE OF MEDICAL
SCIENCES
BANGALORE 560004.
11.4 SIGNATURE
3
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12.1 REMARKS OF THE PRINCIPAL
12.2 SIGNATURE
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6. BRIEF RESUME OF INTENDED WORK
6.1 NEED FOR THE STUDY
Spinal anesthesia is the most commonly used technique for lower abdominal surgeries 1. By adding a
small dose of narcotics to local anaesthetic solution the duration of anaesthesia and analgesia can be
significantly prolonged2 .
Intrathecal
opiods
enhance the sensory blockade of
local anesthetics without affecting the
sympathetic activity3. Intrathecal morphine provides prolonged postoperative analgesia but is
associated with increased risk of nausea, vomiting, itching and respiratory depression4.
Short acting opiods like fentanyl and sufentanil have been used intrathecally in elderly population to
provide pain relief 5. Buprenorphine a mu receptor agonist with low intrinsic activity can also be
administered safely in the subarachnoid space6.. When used intrathecally in combination with
bupivacaine it has known to improve the quality and duration of postoperative analgesia compared to
bupivacaine alone7.
This study will be conducted to evaluate and compare the characteristics of spinal block and its side
effects in adult patients undergoing lower abdominal surgeries who received a subarachnoid block
with either bupivacaine with buprenorphine or bupivacaine with fentanyl.
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6.2) REVIEW OF LITERATURE.

Harbhej singh et al8. Conducted a study on 43 patients undergoing lower extremity or
genitourinary surgery with one group receiving bupivacaine alone and another group receiving
bupivacaine with fentanyl 25 µg, concluded in their study that fentanyl 25 µg , prolonged the
duration of bupivacaine induced sensory block and reduced the analgesic requirement in the
early postoperative period.

Jaishri Bogra et al9. Conducted a study on 120 cesarean section parturients who received a
combination of 12.5 μg intrathecal fentanyl, concluded in their study, the synergistic,
potentiating effect of fentanyl on bupivacaine in spinal anesthesia for cesarian section and
noted that fentanyl is able to reduce the dose of intrathecal bupivacaine.

Rao Sumesh et al10 . Conducted a study on 40 ASA 1 and 2 female patients posted for elective
cesarean section. Patients were randomized into two groups and subarachnoid block
performed with bupivacaine and fentanyl, or bupivacaine alone, concluded from their study
that fentanyl 25 μg, prolonged the duration of bupivacaine induced sensory block and reduced
the analgesic requirement in the early postoperative period following bupivacaine spinal
block.

Mohammed Shawagfeh et al11 . Conducted a study on Low-dose Bupivacaine with fentanyl
spinal anesthesia to prevent spinal induced hypotension in adults. The study group (F)
comprised of 50 patients who received spinal anesthesia with Bupivacaine and fentanyl 25
µg, while in control group (B), 50 patients received Bupivacaine only.The hemodynamic
stability of the patients and the quality of the blocks were compared and they concluded that a
reduced dose of Bupivacaine in combination with fentanyl provided reliable spinal anesthesia
with few events of hypotension and little need for vasopressor support for blood pressure.

Sunil Dixit12. Conducted a study on sixty patients scheduled for elective caesarean section
under spinal anesthesia, comparing 0.5% bupivacaine alone versus 0.5% bupivacaine with
60µg
buprenorphine, concluded in their study that intrathecal buprenorphine is a suitable
drug for postoperative analgesia, after cesarean section, it enhances the sensory blockade of
local anesthetics without affecting the sympathetic activity.
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
Sapkal Pravin S et al
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. Conducted a comparative study on intrathecal clonidine 60µg
versus intrathecal buprenorphine 60 µg on 80 patients who were posted for elective or
emergency lower limb surgeries, concluded that intrathecal Buprenorphine gives adequate
analgesia which is significantly longer than that of intrathecal clonidine.

Soumya Samal et al14. Conducted a study on 60 patients of ASA1 and 2 aged between 18
and 50 years of both sexes scheduled for lower abdominal and lower limb surgeries. One
group received 3 ml of 0.5% (H) Bupivacaine with 150 µg Buprenorphine and another group
3ml of 0.5% (H) Bupivacaine with 15 µg Dexmedetomidine diluted to 0.5 ml. Concluded
that the use of Bupivacaine with Buprenorphine (150 µg) in spinal anesthesia provides longer
duration of postoperative analgesia as compared to intrathecal Bupivacaine and
Dexmedetomidine.

F A Khan et al15. Conducted a study on sixty patients scheduled for elective transurethral
resection of prostate (TURP) . One group received hyperbaric bupivacaine 0.75% with
buprenorphine 30 micrograms and another group received hyperbaric bupivacaine 0.75%
with fentanyl 10 micrograms. Demonstrated that the use of bupivacaine with fentanyl (10µg)
spinal anesthesia, resulted in the earlier onset of both sensory and motor block compared to
bupivacaine and buprenorphine 30 µg.
6.3) OBJECTIVES OF THE STUDY
To evaluate and compare the synergistic effect of Bupivacaine 0.5% with Fentanyl versus
Bupivacaine 0.5% with Buprenorphine , in subarachnoid block for lower abdominal surgeries
regarding:
•
Onset and duration of sensory blockade.
•
Onset and duration of motor blockade.
•
Maximum height of sensory block.
•
Time for two segment regression from highest sensory level.
•
Duration of analgesia.
•
Hemodynamic parameters.
•
Complications/side effects, if any.
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7.
MATERIALS AND METHODS
7.1) SOURCE OF DATA
This study will be carried out at the Department of Anesthesiology and Critical care,
Kempegowda
Institute of Medical Sciences, Bangalore.

Study Design: Randomized controlled trial.

Sample Size: Two groups of 50 subjects each.

Duration of study: From December 2013 to September 2015.

Sampling Method: Random sampling.

Statistical Analysis: Student’s t-test, Chi-square test.
7.2) METHOD OF COLLECTION OF DATA
Hundred patients aged between 18 to 60 years of physical status ASA grade 1 and ASA grade 2 of
either sex, undergoing elective lower abdominal surgeries lasting more than 30 minutes will be
included in the study after ethical clearance.
Preoperative evaluation of the patient will be done on the day before surgery. After explaining the
procedure, written and informed consent will be obtained.
Patient will be advised overnight fasting and are premedicated with tablet Alprazolam 0.5 mg the
night before and on the day of surgery.
INCLUSION CRITERIA
•
All the patients who are posted for elective lower abdominal surgeries
•
Age group- 18- 60 years, of either sex.
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•
ASA 1 and 2.
•
Weight 50-80 kg.
•
Height > 150cm.
EXCLUSION CRITERIA
•
Allergy to local anesthetics and opioids.
•
Local infection.
•
Pregnancy and lactation.
•
Raised intracranial tension.
•
Progressive neurodegenerative disorder.
•
CNS infections.
•
Spine deformities.
•
Hypovolaemic shock.
•
Bleeding diathesis and coagulopathy.
In the operating room, intravenous line will be secured with 18G cannula and patients will be
preloaded with ringer's lactate solution at 15ml/kg. Patients will be randomized to two groups of 50
each, receiving one of the following for the subarachnoid block:
1. Group F (n=50)- Bupivacaine( 0.5%) 2.5ml with fentanyl 25 µg in 0.5ml
2. Group B (n=50)- Bupivacaine( 0.5%) 2.5ml with buprenorphine 60 µg in 0.5 ml
•
Baseline heart rate, non invasive blood pressure, SPO2, respiratory rate is recorded using
multi-parameter monitor (DATEX OHMEDA), before starting the procedure.
•
Under aseptic precautions with patient in lateral position, 26G Quincke spinal needle will be
introduced into L3-L4 space, after confirming clear flow of CSF and negative aspiration for
blood, 3 ml of test drugs will be injected intrathecally.
•
Intraoperatively, vital parameters like heart rate, non invasive blood pressure, SPO2 will
be recorded every minute for the first 5 minutes, then every 5 minutes till 1 hour of surgery
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and then every 15 minutes till the end of surgery. Postoperatively, every 30 minutes till
the patient complaints of pain.
•
Alteration in the hemodynamic parameters such as hypotension will be treated with injection
Ephedrine in incremental doses of 3mg IV bolus and bradycardia will be treated with injection
Atropine 0.6mg IV bolus.
•
Any adverse events like nausea, vomiting, pruritis, urinary retention etc are noted and treated
accordingly.

Assessment of sensory blockade – tested by pin prick test using hypodermic needle and the
time of onset, highest level of sensory blockade, time for 2 segment regression of sensory
level, duration of sensory block would be noted.

Duration of motor blockade is assessed by Modified Bromage scale.
MODIFIED BROMAGE SCALE
•
0
- Able to perform a full straight leg raise over the bed for 5sec.
1
- Unable to perform a leg raise but can flex the leg on knee.
2
- Unable to flex knee but can flex ankle.
3
- Unable to flex ankle.
4
- Unable to move toes.
Sedation will be assessed with Ramsay sedation scale and recorded. Score of 4 and above is
considered as sedated.
•
RAMSAY SEDATION SCALE
•
1-Patient anxious, agitated or restless.
•
2-Patient cooperative, oriented, and tranquil alert.
•
3-Patient responds to commands.
•
4-Asleep, but with brisk response to light glabellar tap or loud auditory stimulus.
•
5-Asleep, sluggish response to light glabellar tap or loud auditory stimulus.
•
6-Asleep, no response.

Duration of complete analgesia will be assessed from the time of onset of analgesia till the
appearance of pain for first time (first rescue analgesic).

Rescue analgesia is provided with injection Diclofenac 1.5mg/kg slow IV.
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DEFINITIONS

Onset of sensory blockade: It is the time taken from deposition of study drug till the patient
does not feel the pin prick at L1 level.

Onset of motor blockade: Is defined as time taken from deposition of the study drug till the
patient develops modified Bromage scale Grade 3 motor blockade.

Maximum height of sensory blockade: Is defined as the time taken from deposition of the
study drug to the maximum sensory blockade attained.

Time for two segment regression of sensory blockade: It is the time in minutes taken to
regress the level of loss of pin prick sensation achieved to two lower sensory dermatomal
level.

Duration of motor block: Is defined as the time taken from onset of motor block till the
patient attains complete motor recovery (modified Bromage 0).

Hypotension: Is defined as fall in the mean arterial pressure to less than 20% from baseline.

Bradycardia: Is defined as decrease in the heart rate to less than 50 beats/min.
7.3) Does the study require any investigation or intervention to be conducted on patients
or other human or animal? If so, please describe briefly.
No animal experiments included. The following routine pre-operative investigations will be
carried out in both the group of patients after taking written and informed consent.
CBC, BT,CT, ECG, Chest- x ray and other relevant investigations.
7.4) Has ethical clearance been obtained from your institution in case of 7.3?
Yes
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8. LIST OF REFERENCE
1. Rajni Gupta, Reetu Verma, Jaishri Bogra, Monica Kohli, Rajesh Raman, and Jitendra
Kumar Kushwaha. A comparative study of intrathecal dexmedetomidine and fentanyl as
adjuvants to Bupivacaine. J Anaesthesiol Clin Pharmacol 2011 Jul-Sep;27(3):339–343
2.
Sukhani R, Stevens RA. Spinal anesthesia. In: Benzon HT, Raja SN, Borsook D, Molloy
RE, Strichartz G (eds). Essentials of Pain Medicine and Regional Anaesthesia, New York:
Churchill Livingstone 1999;350-7.
3. Wang C, Chakrabarti MK, Whitwam JG.Specific enhancement by fentanyl of the effects of
intrathecal bupivacaine or nociceptive afferent but not on sympathetic efferent pathway in
dogs. Anesthesiology 1993;79:766-73.
4. Chaney MA. Side effects of intrathecal and epidural opioids. Can J Anaesthesia 1995;
42:891-903.
5. Fournier R, Van Gessel E, Weber A, Gamulin Z. A comparison of intrathecal analgesia with
fentanyl or sufentanil in hip replacement. Anesth Analg 2000;90:918-22.
6. Cousins JM, Bridenbough PO. Spinal narcotics and pain relief in acute care. IN: Cousins
MJ, Philips JD, eds. Acute Pain Management New York: Churchill Livingstone, 1986; pp.
156-7.
7. Capogna G, Celleno D, Tagariello V, Loffreda-Maniculli C. Intrathecal buprenorphine for
postoperative analgesia in the elderly patient. Anaesthesia 1988;43:128-30.
8. Harbhej Singh, Jay Yang, Katina Thorton, Adolph H. Giesecke. Intrathecal fentanyl
prolongs sensory bupivacaine spinal block. Canadian journal of anesthesia 1995;42(11):
987-991.
9. Jaishri Bogra, Namita Arora and Pratima Srivastava . Synergistic effect of intrathecal
fentanyl and bupivacaine in spinal anesthesia for caesarian section. BMC
Anesthesiology 2005;5(5):1471-2253.
10. Rao, Sumesh T and Khanooja, Samiksha.A Comparison of Intrathecal Bupivacaine with
Fentanyl to Bupivacaine alone for Elective Caesarian Section. INDIAN JOURNAL OF
RESEARCH 2013; 2(7):204-206 .
11. Mohammed Shawagfeh, Ahmad S Sbaihat, Essa A Mayyas, Ala D Alomari, Safwan G
Fawaris. Low-dose Bupivacaine with fentanyl spinal anesthesia to prevent spinal-induced
hypotension in adults. RMJ 2011;36(2):116-119.
12. Sunil Dixit. Post operative analgesia after caesarean section: an experience with intrathecal
buprenorphine. Indian Journal of Anaesthesia 2007;51(6 ):515-518.
13. Sapkal Pravin S, Kulkarni Kalyani D, Rajurkar Sampda S, Nandedkar Prerna D.
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Comparative study of intrathecal clonidine and intrathecal buprenorphine for postoperative
analgesia after lowerlimb orthopaedic surgery.IJCRR.2013;5(6):87-91.
14. Soumya Samal, P. Rani, Chandrasekar LJ and Saubhagya Kumar Jena. Intrathecal
buprenophine or intrathecal dexmedetomidine for post operative analgesia- A comparative
study. The Health Agenda. 2013;2(1):2320-3749.
15. Khan FA, Hamdani GA. Comparision of intrathecal fentanyl and buprenorphine in
urological surgeries. J Pak Med Assoc 2006; 56(6): 277-81.
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