| CTRI Number |
CTRI/2023/10/058397 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison between epidural tramadol vs epidural buprenorphine for post operative pain relief |
|
Scientific Title of Study
|
comparison of epidural tramadol vs epidural buprenorphine for post operative analgesia in patients undergoing infraumbilical and lower limb surgeries. |
| 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 SHIVANAND P T |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
SHIMOGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaethesiology
3RD Floor, MCgann District Hospital, Shimoga institute of Medical Sciences, Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
9986327599 |
| Fax |
|
| Email |
shivananda1233@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SWATHI M R |
| Designation |
POST GRADUATE |
| Affiliation |
SHIMOGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department OF Anaesthesiology
3RD Floor, MCgann District Hospital, Shimoga Institute Of Medical Sciences, Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
9611889494 |
| Fax |
|
| Email |
swathimr777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SWATHI M R |
| Designation |
POST GRADUATE |
| Affiliation |
SHIMOGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department Of Anaesthesiology
3RD Floor, MCgann District Hospital, Shimoga Institute of Medical Sciences, Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
9611889494 |
| Fax |
|
| Email |
swathimr777@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mcgann district hospital, shimoga institue of medical sciences, shimoga |
|
|
Primary Sponsor
|
| Name |
SHIMOGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Mcgann District Hospital
Shimoga Institute Of Medical Sciences, shimoga
SHIMOGA |
| 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 SWATHI M R |
McGaan DISTRICT HOSPITAL |
Department of Anaesthesiology, 3rd floor,Shimoga Institute Of Medical Sciences, shimoga
Shimoga
KARNATAKA |
9611889494
swathimr777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural Analgesia |
Epidural catheter is placed intraoperativley for post operative analgesia for a duration of 24hours. |
| Comparator Agent |
TRAMADOL AND BUPRENORPHINE |
TRAMADOL 50MG IN 10ML NS
BUPRENORPHINE 0.3MCG IN 10ML NS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2 CATEGORY PATIENTS |
|
| ExclusionCriteria |
| Details |
ASA3&4 CATEGORY PATIENTS, HISTORY OF OPIOID ABUSE, COAGULATION DISORDERS, LOCAL INFECTION AT THE EPIDURAL SITE |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ONSET AND DURATION OF ACTION |
5mins to 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| INTENSITY OF PAIN AND NEED FOR RESCUE ANALGESIA |
5mins to 24hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
24/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/02/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS TO ASCERTAIN A BETTER POST OPERATIVE ANALGESIA BY EPIDURAL ADMINISTRATION OF TRAMADOL AND BUPRENORPHINE IN TERMS OF ONSET ,DURATION OF ACTION, INTENSITY OF PAIN, NEED FOR RESCUE ANALGESIA, SIDE EFFECTS. |