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CTRI Number  CTRI/2024/05/066648 [Registered on: 02/05/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
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   Effectiveness of Buprenorphine Patch applied on skin for post-operative pain in patients undergoing Knee Replacement surgeries. 
Scientific Title of Study   Efficacy of two different doses of Transdermal Buprenorphine Patch for Analgesia in patients undergoing Total Knee Replacement surgery under Spinal Anaesthesia – A Randomized 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  Dr Katta Vani 
Designation  Post Graduate Trainee  
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd floor, Kalinga Institute of Medical Sciences (KIMS), Patia, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9490005116  
Fax    
Email  kattavani48@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sapna Das 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd floor, Kalinga Institute of Medical Sciences (KIMS), Patia, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9078826164  
Fax    
Email  dr.sapnadas88@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr T Rajmohan Rao 
Designation  Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd floor, Kalinga Institute of Medical Sciences (KIMS), Patia, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9701185818  
Fax    
Email  trajmohan.rao@kims.ac.in  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences, Patia, Khordha, Bhubaneswar, Orissa, India. Pincode 751024 
 
Primary Sponsor  
Name  Dr Katta Vani 
Address  Department of Anaesthesiology, 3rd floor, Kalinga Institute of Medical Sciences (KIMS), Patia, Khordha, Bhubaneswar, Orissa, India. Pincode 751024 
Type of Sponsor  Other [SELF] 
 
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 Rajmohan Rao  Pradyumna Bal Memorial Hospital & Kalinga Institute of Medical Sciences  Department of Anaesthesiology, 3rd floor, Patia, Khordha, Bhubaneswar, Orissa, India. Pincode 751024
Khordha
ORISSA 		 9701185818

trajmohan.rao@kims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kalinga Institute Of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Transdermal Buprenorphine Patch for Analgesia  Group 1- Transdermal Buprenorphine Patch of 5 mcg/hour. 
Comparator Agent  Transdermal Buprenorphine Patch for Analgesia  Group 2- Transdermal Buprenorphine Patch of 10 mcg/hour 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients undergoing Total Knee Replacement surgery under Spinal Anaesthesia.
2. American Society Of Anesthesiologists (ASA) physical status I and II.
3. 18 - 70 years of age of either gender. 
 
ExclusionCriteria 
Details  1. Allergy to Buprenorphine
2. Opioid dependency for more than 3 months
3. Alcoholic Liver Disease, Chronic Kidney Disease 4 and 5
4. Pregnant women
5. Malignancy
6. Patient on any anti-depressants (or) anti-convulsant
7. Morbidly Obese (BMI more than 35) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Total doses of post-operative rescue analgesia requirement.  Up to 72 hours post-operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pain Score by 11-Point Numerical Rating Scale (NRS) at 8th, 24th, 48th and 72nd hours post-operatively.
2. Sedation Score by Ramsay Sedation Score (RSS) at 8th, 24th, 48th and 72nd hours post-operatively.
3. Incidence of adverse effects like Post-Operative Nausea and Vomiting (PONV), Pruritus, Respiratory Depression and Urinary Retention.
4. Hemodynamic Variations like Mean Arterial Pressure (MAP) and Heart Rate (HR).
5. Quality of Recovery Index is calculated based on 15 questions each carrying 0-10 points totalling up to 0-150 and patients are divided into poor, moderate, good and excellent recovery for 0-89, 90-121, 122-135 and 136-150 respectively at 24th, 48th and 72nd hours. 		 1. 11-Point Numerical Rating Scale and Ramsay Sedation Scale score at 8th, 24th, 48th and 72nd hour.
2. Quality of Recovery Index at 24th, 48th and 72nd hours. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2 
Date of First Enrollment (India)   10/05/2024 
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="2"
Months="0"
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   Total Knee Replacement surgery is usually done under Spinal Anaesthesia. Transdermal Buprenorphine Patch provides pain relief for longer duration which is also simple, non-invasive and compliant method of drug delivery. This will lead to early ambulation and early discharge and also have a better quality of recovery. Thus we want to compare the buprenorphine patch of 5mcg/hour with 10 mcg/hour in providing better pain relief with lesser side effects and better quality of recovery. 
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