| CTRI Number |
CTRI/2023/12/060726 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A RANDOMISED DOUBLE BLIND CONTROL STUDY TO COMPARE THE EFFICACY OF TWO DIFFERENT STRENGTH OF BUPRENOPHINE AS A SPINAL ADJUVANT WITH 0.75% ROPIVACAINE IN ADULT PATIENT UNDERGOING OPEN INGUINAL HERNIA SURGERIES. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF EFFICACY OF TWO DIFFERENT STRENGTH OF BUPRENORPHINE AS A SPINAL ADJUVANT TO ROPIVACAINE IN PATIENTS UNDERGOING OPEN INGUINAL HERNIA SURGERIES; A RANDOMISED DOUBLE BLIND CONTROLLED 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 |
Tanu Choudhary |
| Designation |
junior resident |
| Affiliation |
MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
Jawaharlal Girls hostel, Mahatma Gandhi institute of medical sciences,Sevagram,Wardha.
Jawaharlal Girls hostel, Mahatma Gandhi institute of medical sciences,Sevagram,Wardha.
Wardha
MAHARASHTRA
442102
India |
| Phone |
6375427821 |
| Fax |
|
| Email |
tanuchoudhary@mgims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhiraj bhandari |
| Designation |
professor |
| Affiliation |
MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
Mahatma Gandhi institute of medical sciences,Sevagram,Wardha.
Mahatma Gandhi institute of medical sciences,Sevagram,Wardha.
Wardha
MAHARASHTRA
442102
India |
| Phone |
9970195086 |
| Fax |
|
| Email |
dhirajbhandari@mgims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Tanu Choudhary |
| Designation |
junior resident |
| Affiliation |
MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
Jawaharlal Girls hostel, Mahatma Gandhi institute of medical sciences,Sevagram,Wardha.
Jawaharlal Girls hostel, Mahatma Gandhi institute of medical sciences,Sevagram,Wardha.
Wardha
MAHARASHTRA
442102
India |
| Phone |
6375427821 |
| Fax |
|
| Email |
tanuchoudhary@mgims.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MGIMS |
| Address |
SEVAGRAM,WARDHA |
| Type of Sponsor |
Private 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 |
| TANU CHOUDHARY |
MGIMS,KASTURBA HOSPITAL. |
Main operation theatre
Department of Anaesthesia
1st floor, kasturba hospital mgims,Sevagram,wardha
Wardha
MAHARASHTRA |
6375427821
tanuchoudhary@mgims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE, MGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUPRINORHINE |
COMPARISION BETWEEN 2 DIFFERENT STRENGTHS OF BUPRINORPHINE |
| Intervention |
TWO DIFFERENT STRENGTHS OF BUPRENORPHINE |
To compare post operative duration of analgesia in first 24 hours using visual analogue score ( VAS) in adult patient undergoing open inguinal hernia surgeries under spinal anaesthesia with 3.0 ml of 0.75% Ropivacaine with 60 mcg and 90 mcg buprenophine as a spinal adjuvant. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
â— American Society of Anesthesiologists Grade I and II patients.
â— Age above 18 years of any gender
â— Patients undergoing open Inguinal hernia Surgeries.
â— Height is more than 4 feet.
|
|
| ExclusionCriteria |
| Details |
â— American Society of Anesthesiologists Grade III and IV patients.
â— Patients with known contraindications for spinal anaesthesia: bleeding disorders, local infection.
â— Patients with hemodynamic instability.
â— Patient with allergy to or history of hypersensitivity to local anaesthetic.
â— Emergency surgeries.
◠Patient’s refusal.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| POSTOPERATIVE ANALGESIA |
15MINS,1 HR,3HRS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| INTRAOP HEMODYNAMIC PARAMETRES AND TIME FOR SENSORY AND MOTOR BLOCK |
5MINS,15MINS,30 MINS,45 MINS |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
21/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/01/2024 |
| 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
|
TO COMPARE TWO DIFFERENT STRENGTHS OF BUPRINORPHINE ON POSTOPERATIVE ANALGESIA,INTRAOP HEMODYNAMIC CHANGES,TIME FOR SENSORY AND MOTOR BLOCK |