| CTRI Number |
CTRI/2026/02/103092 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different doses of intrathecal buprenorphine with 0.75 percent hyperbaric ropivacaine in elective caesarean sections. |
|
Scientific Title of Study
|
Comparison of two different doses of intrathecal buprenorphine with 0.75% hyperbaric ropivacaine in elective caesarean section for post operative analgesia. A randomized 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 |
Dr Harish T |
| Designation |
Junior Resident |
| Affiliation |
Shri B. M. Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Third floor, shri B. M. Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
8667747476 |
| Fax |
|
| Email |
harishthanu1010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha S D |
| Designation |
Professor |
| Affiliation |
Shri B. M. Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Third floor, shri B. M. Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9036110082 |
| Fax |
|
| Email |
Pratibhakaradi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha S D |
| Designation |
Professor |
| Affiliation |
Shri B. M. Patil Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Third floor, shri B. M. Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9036110082 |
| Fax |
|
| Email |
Pratibhakaradi@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE DUShri BM patil medical college |
|
|
Primary Sponsor
|
| Name |
Dr Pratibha S D |
| Address |
Shri B. M. Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka, India.586103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Harish T |
BLDE DU , Shri BM patil medical College |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harish |
BLDE DU, SHRI BM PATIL MEDICAL COLLEGE |
Vijayapura
Bijapur
KARNATAKA |
8667747476
harishthanu1010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE ( deemed to be university) institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women of 18 to 40 years scheduled for elective caesarean section.
|
|
| ExclusionCriteria |
| Details |
Contraindications to spinal anaesthesia, opioid allergy, pregnancy related complications like preeclampsia, known systemic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, severe hepatic and renal diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the onset and duration of motor and sensory blockade and to evaluate the pain intensity using VAS score |
To check pain intensity post surgery at 1, 2, 4, 6, 12, 24 hours |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pre anaesthetic evaluation will be done bedside and all routine investigations noted. Patient will be kept nil per oral for 8 hours. Patients will be positioned and spinal anaesthesia will be carried out by anaesthesiologist under strict aaeptic precautions. After explaining the procedure informed written consent will be obtained. Group 1 will receive 30mcg of of buprenorphine with 0.75% hyperbaric ropivacaine while group 2 will receive 60mcg of buprenorphine with 0.75% hyperbaric ropivacaine. Vitals will be monitored throughout the procedure and post operatively. Time for onset and duration of motor and sensory blockade, time to first request for analgesia, VAS score at 1, 2, 4, 6, 12, 24 hours, numer of rescue analgesics in first 24 hours, incidence of adverse events and APGAR score of the newborn will be noted. |