| CTRI Number |
CTRI/2025/03/083412 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of transdermal buprenorphine and transdermal diclofenac patch for post operative pain relief in major surgeries. |
|
Scientific Title of Study
|
A comparative study of analgesic efficacy between transdermal buprenorphin patch and transdermal diclofenac patch for post operative pain relief in major 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 Anvita Shainy Lakra |
| Designation |
Junior Resident |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Department of Anaesthesiology 4th floor room number 418, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Pendri Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
09893676330 |
| Fax |
|
| Email |
anvitashainy738@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Durga Kashyap Kosam |
| Designation |
Professor and Head of Department |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Department of Anaesthesiology 4th floor room number 418, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Pendri Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9826075062 |
| Fax |
|
| Email |
Kosamdurga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durga Kashyap Kosam |
| Designation |
Professor and Head of Department |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Department of Anaesthesiology 4th floor room number 418, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Pendri Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9826075062 |
| Fax |
|
| Email |
Kosamdurga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharat Ratan Late Shri Atal Bihari vajpayee memorial medical College, pendri,rajanandgaon,Chhattisgarh,india 491441 |
|
|
Primary Sponsor
|
| Name |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College |
| Address |
Department of Anaesthesiology and Critical care, 4th floor room number 418, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Pendri Rajnandgaon |
| 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 Anvita Shainy Lakra |
BHARAT RATNA LATE SHRI ATAL BIHARI VAJPAYEE MEMORIAL MEDICAL COLLEGE RAJNANDGAON |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, 4TH FLOOR, ROOM NO.418,BHARAT RATNA LATE SHRI ATAL BIHARI VAJPAYEE MEMORIAL MEDICAL COLLEGE, PENDRI RAJNANDGAON, CHHATTISGARH, INDIA 491441 RAJNANDGAON, CHHATTISGARH
Rajnandgaon
CHHATTISGARH |
9893676330
anvitashainy783@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BRLSABVM MEDICAL COLLEGE RAJNANDGAON |
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 |
Application of trans-dermal Patch |
Trans-dermal Patches will be applied on lateral aspect of left arm preoperatively and will be kept for 24 hours after complete recovery from general or spinal anaesthesia in each group. |
| Comparator Agent |
Trans-dermal Buprenorphine Patch |
Medicine name: Buprenorphine 10mg. each patch delivers 10mcg/hr.
Administration: Trans-dermal application of Buprenorphine patch will be done night before the surgery by a person
not involved in the study and will be kept for 24 hours after complete recovery from general or spinal anaesthesia.
Reference: Package Insert |
| Comparator Agent |
Trans-dermal Diclofenac Patch |
Medicine name: Diclofenac Diethylamine 100mg.
Administration: Trans-dermal application of diclofenac patch 2 hours before the surgery by a person not involved in the study and patch will be kept for 24 hours after complete recovery from general or spinal anaesthesia.
Reference: Package Insert |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group: 18-60 years
Patients posted for elective major surgeries under general anesthesia or spinal anesthesia with ASA-1 or ASA-2 grade
|
|
| ExclusionCriteria |
| Details |
.Patients refusal
.Pregnant and lactating women
.Age more than 60 years
.ASA grading more than or equal to 3
.History of allergy to Buprenorphine, Diclofenac, Paracetamol
.Opioid Dependents
.Cardiac, kidney, Liver disease and coagulation disorders
.Patients with pain due to cause other than presenting illness |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
.Visual analog scale after complete recovery from general or spinal anaesthesia in group with Buprenorphine patch.
.Visual analog scale after complete recovery from general or spinal anaesthesia in group with Diclofenac patch. |
0, 2nd, 4th, 8th, 12th, 24 hour after complete recovery from general or spinal anaesthesia in group with Buprenorphine patch and Diclofenac patch. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.Total rescue analgesia required in group with Buprenorphine patch and diclofenac patch
.Comperision of sode effects and complication in group with Buprenorphine patch and Diclofenece patch. |
0,2nd,4th,8th,12th,24hour after complete recovery from general or spinal anaesthesia patch and diclofenac patch |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
10/04/2025 |
| 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="0"
Months="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anvitashainy738@gmail.com].
- For how long will this data be available start date provided 30-01-2025 and end date provided 11-02-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
I want to conduct " A Comparative study of analgesic efficacy between transdermal buprenorphine patch and transdermal diclofence patch for post operative pain relief in major surgeries" for my MD Anaesthesia thesis.
AIM: This study aims to compare the efficacy of post operative pain relief with transdermal buprenorphine patch and transdermal diclofence patch.
OBJECTIVES: 1. Evaluation of post operative pain after complete recovery from general or spinal anaesthesia in group Buprenorphine using visual analog scale at 0, 2nd , 4th, 8th, 12th, 24th hours. 2. Evaluation of post operative pain after complete recovery from general or spinal anaesthesia in group Diclofence using visual analog scale at 0, 2nd , 4th, 8th, 12th, 24th hours. 3. To Comparison of total rescue analgesia required in both groups. 4. Side effects and complications in group Buprenorphine and group Diclofence .
SETTING: Bharat Ratan Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon, Chhattisgarh
STUDY DESIGN: Prospective, Rendomized, Double blind, Interventional Study.
TIME FRAME: - February 2025 - April 2025
POPULATION/PARTICIPANTS: Patient between 18-60 years old, scheduled for major surgeries under general anaesthesia or spinal anaesthesia.
SAMPLE SIZE: Sample size of this study is taken as 62 with 31 sample in each group .
METHODS: Informed and written consent, Pre-anaesthetic evaluation, application of transdermal buprenorphine and diclofence patch. Pre operative monitoring and medication, IV Access, Sub Arachnoid Block, General Anaesthesia, Proposed surgery, post operative pain assessment on VAS Scale
OUTCOME MEASURES: 1. Pain score on VAS Scalef or transdermal buprenorphine Patch. 2. Pain score on VAS Scalef or transdermal diclofence patch. 3. Total dose of rescue analgesia consumed. 4. Side effect in each group.
STATISTICAL ANALYSIS: Statistical analysis will be performed by the SPSS program for Windows, version 20.0. continuous variables will be presented as mean +/- SD, and categorical variables will presented as absolute numbers and percentage. Data will checked for normality before statistical analysis. Comparison of mean for normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that will not be normally distributed. Categorical variables will be analyzed using either the chi square test or Fisher’s exact test . |