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CTRI Number  CTRI/2022/06/043482 [Registered on: 24/06/2022] Trial Registered Prospectively
Last Modified On: 15/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study pain relief effects of two drugs, buprenorphine and fentanyl which are applied as patches below curved front bone of the shoulder in patients undergoing surgeries involving female reproductive system. 
Scientific Title of Study   Comparative evaluation of transdermal buprenorphine and transdermal fentanyl for Postoperative Pain Relief after gynaecological Surgeries – a prospective randomized study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sneka Priyadharsini V 
Designation  Second year post graduate 
Affiliation  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research 
Address  Department of Anaesthesiology, OG operation theatre and post operative recovery room, operation theatre complex, B zone , ground floor, hospital block.

Kancheepuram
TAMIL NADU
603319
India 
Phone  9488319024  
Fax  044-27528305  
Email  snekamohan95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prasath C 
Designation  Professor 
Affiliation  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research 
Address  Department of Anaesthesiology, Melmaruvathur Adhiparasakthi institute of medical sciences and research,Melmaruvathur, Kancheepuram District, Tamilnadu, India 603319

Kancheepuram
TAMIL NADU
603319
India 
Phone  9787740890  
Fax  044-27528305  
Email  drpathin2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sneka Priyadharsini V 
Designation  Second year post graduate 
Affiliation  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research 
Address  Department of Anaesthesiology, Melmaruvathur Adhiparasakthi institute of medical sciences and research,Melmaruvathur, Kancheepuram District, Tamilnadu, India 603319

Kancheepuram
TAMIL NADU
603319
India 
Phone  9488319024  
Fax  044-27528305  
Email  snekamohan95@gmail.com  
 
Source of Monetary or Material Support  
Melmaruvathur Adhiparasakthi Institute of Medical sciences and Research,Melmaruvathur,Kancheepuram district,Tamilnadu,India 603319 
 
Primary Sponsor  
Name  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research 
Address  Melmaruvathur, Kancheepuram District, Tamilnadu, India 603319 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSneka Priyadharsini V  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research  Department of Anaesthesiology, OG operation theatre and post operative recovery room, operation theatre complex, B zone , ground floor, hospital block.
Kancheepuram
TAMIL NADU 		 9488319024
044-27528305
snekamohan95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,Melmaruvathur Adhiparasakthi institute of medical sciences and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Buprenorphine transdermal patch (20 mcg/hr)  Buprenorphine transdermal patch at a dose of 20 mcg/hr will be applied over subclavian area for patients undergoing gynaecological surgeries and patients will be observed for 72 hours following surgery 
Comparator Agent  Fentanyl transdermal patch(25mcg/hr)  Fentanyl transdermal patch at a dose of 25 mcg/hr will be applied over subclavian area for patients undergoing gynaecological surgeries and patients will be observed for 72 hours following surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Women (Age-18 – 60 ).
ASA classes I to III.
Those posted for transabdominal gynecological surgeries performed with pfannenstiel incision. 
 
ExclusionCriteria 
Details  History of allergy to opioids.
History of ongoing drug/ alcohol abuse.
Patients who are already using a transdermal opioid patch, dependence on opioids.
Pregnant patients.
Combined epidural block.
Patients with abnormal liver or renal function.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the postoperative analgesic efficacy between transdermal buprenorphine and transdermal fentanyl after gynecological surgeries using a visual analog scale (VAS) at rest and movement.  Visual analog scale (VAS) at rest is recorded at postoperative period of 1st,1.5th,2nd,4th,6th,8th,10th,12th,16th,20th,24th,28th,32nd,36th,40th,44th,48th,72nd hours.
Visual analog scale (VAS) at movement is recorded at postoperative period of 24th,28th,32nd,36th,40th,44th,48th,72nd hours.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the total amount of rescue analgesic consumption in the postoperative period.  postoperative period from 1st to 72nd hours 
To compare the time to rescue analgesia between the groups.  Postoperative period from 1st to 72nd hours. 
To compare hemodynamic variations such as heart rate (HR), Respiratory rate (RR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation (SPO2) between the groups.  preoperative period (baseline),postoperative period at 1st,1.5th,2nd,4th,6th,8th,10th,12th,16th,20th,24th,28th,32nd,36th,40th,44th,48th,72nd hours. 
To compare the side effects between the groups.  postoperative period from 1st to 72nd hours. 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   28/06/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  snekamohan95@gmail.com

  6. For how long will this data be available start date provided 16-06-2022 and end date provided 16-06-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a prospective randomized study comparing evaluation of transdermal buprenorphine and transdermal fentanyl for postoperative pain relief after gynaecological surgeries that will be conducted in Melmaruvathur adhiparasakthi institute of medical sciences and research. Primary outcome will be postoperative analgesic efficacy between the groups. Secondary outcome will be time to rescue analgesia between the groups, total amount of rescue analgesic consumption, hemodynamic parameters( heart rate, respiratory rate,systolic blood pressure, diastolic blood pressure, mean arterial pressure, oxygen saturation) and anticipated side effects between groups in post operative period from first to seventy second hour. 
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