FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/10/037638 [Registered on: 27/10/2021] Trial Registered Prospectively
Last Modified On: 22/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON 0F TRANSDERMAL BUPRENORPHINE VERSUS TRANSDERMAL FENTANYL FOR POST-OPERATIVE ANALGESIA  
Scientific Title of Study   COMPARISON 0F TRANSDERMAL BUPRENORPHINE PATCH VERSUS TRANSDERMAL FENTANYL PATCH FOR POST-OPERATIVE ANALGESIA AFTER FEMUR SURGERIES UNDER REGIONAL ANAESTHESIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BASAVARAJ ARAKERI 
Designation  anaesthesia pg 
Affiliation  KIMS Hubbali 
Address  Department of anaesthesia KIMS Hubli
KIMS Hubli
Dharwad
KARNATAKA
580021
India 
Phone  08050718722  
Fax    
Email  drbasavaraj.arakeri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  BASAVARAJ ARAKERI 
Designation  anaesthesia pg 
Affiliation  KIMS Hubbali 
Address  Department of anaesthesia KIMS Hubli
KIMS Hubli
Dharwad
KARNATAKA
580021
India 
Phone  08050718722  
Fax    
Email  drbasavaraj.arakeri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swarnamba U N 
Designation  Associat professor 
Affiliation  Kim’s Hubli  
Address  Department of anaesthesia Kim’s Hubli
KIMS Hubli
Dharwad
KARNATAKA
580021
India 
Phone  9448559776  
Fax    
Email  drswarnmba@rediffmail.com  
 
Source of Monetary or Material Support  
Karnataka institute of medical sciences Hubli 
 
Primary Sponsor  
Name  Karnataka institute of medical sciences  
Address  Karnataka institute of medical sciences Vidyasagar Hubli  
Type of Sponsor  Government 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 
dr basavaraj arakeri  karnataka institute of medical science hubli  Department of anaesthesia KIMS Hubli
Dharwad
KARNATAKA 		 08050718722

drbasavaraj.arakeri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Karnataka institute of medical science Hubli Ethics committee (Reg No - ECR/486/Inst/KA/2013/RR-16  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S72||Fracture of femur, (2) ICD-10 Condition: S723||Fracture of shaft of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Transdermal Buprenorphine patch 10mg.  10mg Buprenorphine patch will be applied 12hrs before surgery to the patients on hairless area of chest,back and upper arm. 
Comparator Agent  Transdermal Fentanyl patch 2.5mg  2.5mg transdermal Fentanyl patch will be applied to the patient 12hrs before surgery on hairless area of chest, shoulder, arm. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  age group: 20 - 50 years.
patients belonging to ASA 1 and ASA 2.
Patient giving informed written and valid consent.
 
 
ExclusionCriteria 
Details 
o Patient with history of allergy to drugs.
o Opioid dependent and sensitive patients.
o Pregnant and breastfeedingf emales.
o Having impaired pulmonary function.
o H/O Alcohol abuse.
o Haemo-dynamically unstable.
o Hepatic dysfunction,renal impairment.
o Patients on anti-depressant drugs.
o Morbidly obese.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic efficacy and safety as assessed with the occurrence of side effects.  Per-op, 0hrs, 4th hrs, 8th hrs, 12th hrs, 18 th hrs, 24th hrs,36th hrs, 48th hrs, 60th hrs and 72 th hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
the quality of analgesia interms of requirement of rescue analgesia.
2)To study the effects of drugs on haemodynamics 		 Per-op, 0hrs, 4th hrs, 8th hrs, 12th hrs, 16th hrs, 20th hrs, 24th hrs, 36th hrs, 48th hrs, 60th hrs and 72th hrs. 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   29/10/2021 
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   NIL 
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
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

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

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included yes).

  6. For how long will this data be available start date provided 30-09-2021 and end date provided 30-04-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Fentanyl 2.5mg transdermal patch is better in providing postoperative analgesia with minimum side effects. Buprenorphine 10mg transdermal patch give us postoperative pain relief with some side effects. 
Close