PROFORMA FOR REGISTRATION OF SUBJECT FOR

PROJECT

A COMPARATIVE STUDY OF LOW DOSE

1. TITLE OF THE TOPIC
HYPERBARIC BUPIVACINE WITH
FENTANYL AND HYPERBARIC
BUPIVACAINE IN SPINAL ANAESTHESIA
FOR BELOW UMBILICAL SURGERIES.
DR. TAHIR S HATTURKAR AND
DR.SHEELA.S

PRINCIPAL INVESTIGATOR WITH DEPARTMENT OF ANESTHESIOLOGY

2.
NAME OF THE DEPARTMENT MVJ MEDICAL COLLEGE AND RESEARCH
HOSPITAL, HOSKOTE BANGALORE-562114

DR. NIRMALA.B.C

CO-INVESTIGATOR WITH NAME OF DEPARTMENT OF ANESTHESIOLOGY

3.
THE DEPARTMENT MVJ MEDICAL COLLEGE AND RESEARCH
HOSPITAL, HOSKOTE BANGALORE-562114
APPROVAL OF THE HEAD OF
4. OBTAINED
DEPARTMENT
DECEMBER 2018 TO NOVEMBER 2019.
5. PROPOSED TIME PERIOD

PROPOSED DATE OF DECEMBER 2018

6.
COMMENCEMENT
PROPOSED BUDGET NIL
7.
NAMES OF FUNDING AGENCY IF ANY NOT APPLICABLE
8.
DOES IT MEETS ALL YES
9. REQUIREMENTS OF THE ETHICAL
COMMITTEE ?:
TECHNICAL FEASABILITY : YES
10
YES
11 PATIENT FEASABILITY :
APPLIED

12 ETHICALLY CLEAR :
6.1 AIMS AND OBJECTIVES OF THE STUDY:

GENERAL OBJECTIVES :-

The aim of my study is to compare the efficacy of intrathecal 1.5ml hyperbaric bupivacaine
0.5% and 50mcg of fentanyl with 3ml of hyperbaric bupivacaine with regard to :-

1. Onset of sensory block

2. Onset of motor block.

3. Highest level of the block at the end of 20 minutes after giving spinal anaesthesia.

4. Regression of two segments.

5. Duration of motor block

6. Duration of analgesia.

7. Intraoperative hemodynamic stability.

8. Adverse effects.

MATERIALS AND METHODS :

STUDY DESIGN :- Randomized prospective and comparative study.

SOURCE OF DATA :-

60 patients of ASA I,II and III belonging to both sexes admitted for elective below umibilical
surgeries under spinal anesthesia at MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL,
HOSKOTE, BANGALORE during the period of DECEMBER 2018 TO NOVEMBER 2019.

MODE OF SELECTION OF STUDY POPULATION :- Random selection

METHOD OF COLLECTION OF DATA:

INCLUSION CRITERIA:
1. Patients of ASA grade: I to III.
2. Patients of both the sexes posted for below umbilical surgeries.
3. Patients giving valid informed and written consent.
4. Patients from 150-165cm height.

EXCLUSION CRITERIA:

1. Patient’s refusal/contraindications for spinal anaesthesia.

2. Patients with History of Hypersensitivity to the drugs used.
3. Patients below 35kgs and above 90kgs are excluded.

METHODOLOGY:
After obtaining Institutional Ethical Committee clearance and written informed consent from the patients, a
randomized prospective study involving 60 patients belonging to American society of anaesthisiologists
(ASA) physical status I to III will be enrolled for the study.

 Routine pre-anaesthetic checkup of all the patients will be done.

 The enrolled patients will be randomly divided into two groups of 30 each.
Group A -will receive intrathecal 1.5ml of 0.5% hyperbaric bupivacaine with 50mcg fentanyl.
Group B- will receive intrathecal 3ml of 0.5% hyperbaric bupivacaine(Control group).

 Under aseptic precautions, Subarachnoid block will be given in lateral position at L2-L3 intervertebral
disc space using a 25 G Quincke’s needle through midline approach and table in neutral position.
Patients will be turned supine immediately.

The following points are noted: -

1. Onset of sensory block: the time of onset will be taken from the time of injection of the drug
into the subarachnoid space to the loss of pin prick sensation at T10.

2. Onset of motor block:the time interval between injection of the drug into subarachnoid space
to the patients inability to move the ankle joint.

3. Level of the sensory block: is defined as level achieved at the end of 20 minutes after spinal
anaesthesia.

4. Duration of motor block: is defined as the time taken for the patient to move knee joint from
 the onset of motor block.

5. Duration of two segment sensory regression: is defined as the time taken from the
maximum of level of sensory block attained till the sensation has regressed by two segments.

6. Duration of analgesia: is defined as the time taken from the completion of the injection of
study drug till the patient request for rescue analgesic in the postoperative period.

7. Parameters like HR, BP, SPO2 are recorded every 2 mins for the first 10 minutes and every 10
minutes till the end of surgery.
8. Any other adverse drug reactions like nausea, vomiting, urinary retention, pruritis etc will be
noted.

Does the study require any investigation or intervention to be conducted on patients or other humans
or animals?
The study requires only routine investigations.
No animal studies required.

REVIEW OF LITERATURE :

1. Singh H, Yang J. Intrathecal fentanyl prolongs sensory bupivacaine block.

The present study shows that, in elderly patients, adding 25μg of fentanyl to bupivacaine during

spinal anaesthesia does not alter the latency of sensory and motor block/duration of motor block
but

prolongs the duration of sensory block, reduces intraoperative discomfort and decreases the pain

intensity in postoperative period.

2. Dahlgren G, Martin H, Hulstrand C.Intrathecal sufentanyl, fentanyl or placebo added to

bupivacaine for caesarean section.

Concluded that fentanyl does not alter onset of sensory or motor block but prolongs duration of

sensory block without prolonging recovery of motor block.

3. Khanna MS; Singh IKJP Comparative evaluation of bupivacaine plain versus bupivacaine with
 fentanyl in spinal anaesthesia in geriatric patients.

Concluded that in inducing spinal nerve block, fentanyl plus bupivacaine does not changes the

latency of sensory and motor block in geriatric patients undergoing hip replacement surgery.

4. Shah S, Shah B, Deb C. A study of comparative evaluation of bupivacaine plain versus

bupivacaine with fentanyl in spinal anaesthesia in geriatric patients.

Concluded that spinal anesthesia with 2cc bupivacaine 0.5% and 25 μg fentanyl is a better option

for elderly patients undergoing lower limb surgeries, with lower incidence of complications
without

compromising the surgical situations.

5. Kuusniemi KS, Pihlajamaki KK, Pitkanen MT, et al.

The use of bupivacaine and fentanyl for spinal anaesthesia for urologic surgery.

Concluded in their study that patients in the fentanyl group had a significantly lesser degree of
motor blockade and all other sensory parameters were observed to be preserved with few could

perceive touch and pressure, proprioception was also preserved in these cases.

6. Prajapati J , Parmar H . Low dose bupivacaine and bupivacaine with fentanyl for spinal
anaesthesia for transurethral resection of prostate.

Concluded in their study that intrathecal bupivacaine 5mg combined with fentanyl 25mcg provided
adequate anaesthesia for transurethral resection of prostate in elderly patients and is assosciated with
lower incidence of hypotension and shivering than a conventional dose of bupivacaine. The addition
of fentanyl improves the quality of block, increases the duration of sensory block and makes the
blockade haemodynamically more stable than conventional dose of bupivacaine.

7. Kotwani, M.B, Rupwate, K., Shivananda, P., & Magar, J (2016,08). Comparison between high dose
hyperbaric Bupivacaine (12.5 mg) alone versus low dose hyperbaric Bupivacaine (7.5 mg) with
Fentanyl (25 µg) in spinal anaesthesia for inguinal hernia surgery.
In our study, we observed that low dose Bupivacaine with Fentanyl gives adequate intraoperative analgesia
& thus making it a reliable anaesthetic alternative. And also profound hemodynamic stability, better
postoperative analgesia with faster recovery from motor block, reducing recovery room stay without
increasing any other side effects like sedation, respiratory depression, or pruritus as compared to conventional
high dose Bupivacaine was observed. So, we conclude that low dose Bupivacaine with Fentanyl is a better
choice for spinal anaesthesia for inguinal herniorrphaphy as compared to conventional high dose
Bupivacaine.

8. Venkata, H., Porika, S., Talari, G., Pasupuletti, S., & Pabba, U (2015). A randomized
controlled prospective study comparing a low dose bupivacaine and fentanyl mixture to a conventional dose of
hyperbaric bupivacaine for cesarean section.
Based on the present clinical comparative study, we conclude that the addition of 25 μg of fentanyl to 7.5 mg of
hyperbaric bupivacaine in spinal anesthesia for elective cesarean section shows faster onset of sensory block with
better hemodynamic stability and significantly prolong postoperative analgesia than hyperbaric bupivacaine alone.

REFERENCES :

1. Singh H, Yang J.Intrathecal fentanyl prolongs sensory bupivacaine block. Cand. J. Anaesth,
1995; 42(11):987-91.

2. Dahlgren G, Martin H, HulstrandC. Intrathecal sufentanyl, fentanyl or placebo added to

bupivacaine for caesarean section. J. Anaesthesia,Analgesia, 1997; 85(6):1288-83

3. Khanna MS; Singh IKJP Comparative evaluation of bupivacaine plain versus bupivacaine
with fentanyl in spinal anaesthesia in geriatric patients. Indian Journal of Anaesthesia.
2002;46:199-203.

4. Shah S, Shah B, Deb C. A study of comparative evaluation of bupivacaine plain versus

bupivacaine with fentanyl in spinal anaesthesia in geriatric patients. International Journal of
Medical and Health Research. 2016;2:23-26.

5. Kuusniemi KS, Pihlajamaki KK, Pitkanen MT, et al. The use of bupivacaine and fentanyl for
spinal anaesthesia for urologic surgery. Anaesth Analg 2000;91(6):1452- 1456.
6. Prajapati J , Parmar H . Low dose bupivacaine and bupivacaine with fentanyl for spinal
anaesthesia for transurethral resection of prostate. IAIM 2015;2(9) :11-19.
7. Kotwani, M.B, Rupwate, K., Shivananda, P., & Magar, J (2016,08). Comparison between
high dose hyperbaric Bupivacaine (12.5 mg) alone versus low dose hyperbaric Bupivacaine
(7.5 mg) with Fentanyl (25 µg) in spinal anaesthesia for inguinal hernia surgery. International
journal of clinical trials, 3(3), 140. doi:10.18203/2349-3259.ijct20162795
8. Venkata, H., Porika, S., Talari, G., Pasupuletti, S., & Pabba, U (2015). A randomized
controlled prospective study comparing a low dose bupivacaine and fentanyl mixture to a
conventional dose of hyperbaric bupivacaine for cesarean section. Saudi journal of
anaesthesia ,9(2),122,.doi:10.4103/1658-345x.152827