| CTRI Number |
CTRI/2026/04/108965 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two drugs namely Fentanyl and Buprenorphine by adding to 0.5% Hyperbaric Bupivacaine a spinal anaesthesia drug used for lower abdominal surgeries: A Randomised Clinical Trial |
|
Scientific Title of Study
|
A comparative study of the effect of intrathecal Fentanyl and Buprenorphine as an adjuvant to 0.5% Hyperbaric Bupivacaine for infraumbilical surgeries under spinal anaesthesia: A Randomised Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Takhellambam Shamananda Singh |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
8310675558 |
| Fax |
|
| Email |
shama.takhell@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Takhellambam Shamananda Singh |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
8310675558 |
| Fax |
|
| Email |
shama.takhell@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maharambam Binarani |
| Designation |
Assistant Professor |
| Affiliation |
Regional Institute of Medical Sciences Imphal Manipur |
| Address |
Department of Anaesthesiology
Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9862133825 |
| Fax |
|
| Email |
bina.maharambam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur, India, Pin- 795004 |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Lamphelpat, Imphal,Manipur, India, Pin -795004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Takhellambam Shamananda Singh |
Regional Institute of Medical Sciences |
Department of Anaesthesiology Lamphelpat, Imphal West, Manipur, India, Pin-795004
Imphal West
MANIPUR |
8310675558
shama.takhell@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K352||Acute appendicitis with generalized peritonitis, (2) ICD-10 Condition: N700||Acute salpingitis and oophoritis, (3) ICD-10 Condition: N400||Benign prostatic hyperplasia without lower urinary tract symptoms, (4) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (5) ICD-10 Condition: N200||Calculus of kidney, (6) ICD-10 Condition: N201||Calculus of ureter, (7) ICD-10 Condition: N711||Chronic inflammatory disease of uterus, (8) ICD-10 Condition: K650||Generalized (acute) peritonitis, (9) ICD-10 Condition: M223||Other derangements of patella, (10) ICD-10 Condition: M971||Periprosthetic fracture around internal prosthetic knee joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buprenorphine |
Adjuvant drug to be used, in the dose of 150 microgram which is 0.5 millilitre, with 12.5 milligram of 0.5 percent Hyperbaric Bupivacaine heavy which is 2.5 millilitre. Total intrathecal volume in each group will be 3 millilitres. |
| Comparator Agent |
Fentanyl |
Adjuvant drug to be used,in the dose of 25 microgram which is 0.5 millilitre, with 12.5 milligram of 0.5 percent Hyperbaric Bupivacaine heavy which is 2.5 millilitre. Total intrathecal volume in each group will be 3 millilitres. |
| Intervention |
Hyperbaric Bupivacaine Heavy |
Drug for Spinal Anaesthesia in the dose of 12.5 milligram which is 2.5 millilitre in the form of 0.5 percent Hyperbaric Bupivacaine together with the 0.5 millilitre of comparator agent. Total intrathecal volume in each group will be 3millilitres. The duration of intervention will be 3 hours starting of intrathecal injection to the post operative follow up as per the protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 60 years of either sex undergoing spinal anaesthesia for elective infraumbilical surgeries, such as surgical procedures on lower abdomen, genitourinary region including gynaecological and urological surgeries
2. Patients of American Society of Anaesthesiologists (ASA) grade 1 or 2
3. Either sex |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactation
2. Uncooperative patient and patient refusal to give consent
3. Patient with history of allergy to the drugs(hyperbaric Bupivacaine, Fentanyl, Buprenorphine)
4. Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled thyroid disorder, height more than 180 cm or height less than 140 cm and weight more than 110 kgs or weight less than 45 kgs
5. Patients with cardiovascular, respiratory, renal, hepatic or neurological disease
6. Patients contraindicated for spinal anesthesia such as local site infection, spinal deformity, patient with bleeding disorder-platelet count more than 50000/microliter, prothrombin time ore than 14 seconds, INR more than 1.5 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia between the study groups |
After the intrathecal injection, parameters as per the protocol will be recorded every 2 minutes for the first 10 minutes and every 5 minutes till 30 minutes and every 10 minutes till 60 minutes and every 30 minutes till 180 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the onset time of sensory & motor block between the the two groups
2. To assess the duration of sensory & motor block achieved with each adjuvant
3. To assess the hemodynamic stability
4. To identify the adverse effects |
After the intrathecal injection every parameters as per the protocol will be recorded every 2 minutes for the first 10 minutes & every 5 minutes till 30 minutes & every 10 minutes till 60 minutes & every 30 minutes till 180 minutes |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective, randomized, double blinded study study will be conducted in the Department of Anesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur. The study will involve 120 patients scheduled for infraumbilical surgeries with intrathecal injection of either 3ml of 12.5 milligram of 0.5 percent hyperbaric bupivacaine with fentanyl 25 microgram or 3ml of 12.5 milligram of hyperbaric bupivacaine with 150 microgram of Buprenorphine. The patients will be randomly divide into two groups of 60 each. Group BF will receive 3ml of 12.5 mg of 0.5 percent hyperbaric bupivacaine with Fentanyl of 25 microgram and Group BB will receive 3ml of 12.5 milligram of 0.5 percent hyperbaric Bupivacaine with 150 microgram of Buprenorphine injected intrathecally. The quality of surgical anesthesia, motor and sensory blockades, hemodynamic changes, duration of the analgesia as well as the side effects will be noted for the two groups. All the findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analyzed and inference will be drawn to evaluate and compare the two drugs with their clinical advantages and side effects. |