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CTRI Number  CTRI/2022/08/044612 [Registered on: 03/08/2022] Trial Registered Prospectively
Last Modified On: 28/07/2022
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   Comparison of two different drug effect for postoperative analgesia in Nephrectomy surgery. 
Scientific Title of Study   Comparative study of Tramadol and Buprenorphine Transdermal patch for postoperative analgesia in Nephrectomy surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prakash Gangwani 
Designation  Junior resident 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  Department of Anaesthesiology, Critical care and Pain Management,Mahatma gandhi medical college and hospital
Mahatma gandhi medical college and hospital,sitapura,jaipur
Jaipur
RAJASTHAN
302022
India 
Phone  9408936833  
Fax    
Email  prakashgangwani54@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Birbal Baj 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  Department of Anaesthesia, Mahatma Gandhi Medical College and hospital
Mahatma Gandhi Medical College and Hospital, Sitapura, Jaipur
Jaipur
RAJASTHAN
302022
India 
Phone  8107788625  
Fax    
Email  birbalbaj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Col RCGupta 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  Department of Anaesthesia, Mahatma Gandhi Medical College and hospital
Mahatma Gandhi Medical College and Hospital, Sitapura, Jaipur
Jaipur
RAJASTHAN
302022
India 
Phone  9352702539  
Fax    
Email  rc.gupta@yahoo.co.in  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Hospital 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College 
Address  Sitapura Jaipur Rajasthan India 
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 
Dr Prakash Gangwani  Mahatma Gandhi Medical College and Hospital  Department Of Anaesthesia, Operation Theatre.
Jaipur
RAJASTHAN 
9408936833

prakashgangwani54@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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, (2) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Buprenorphine Transdermal Patch 10 mcg/hr for duration 7 Days.  Buprenorphine Transdermal patch 10mcg/hr will be applied 12 hrs prior to Nephrectomy Surgery. 
Comparator Agent  Inj Tramadol 100mg OD for 7 Days.  Inj Tramadol 100mg OD will be given just before extubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Grade I/II
Patient UnderGoing Nephrectomy Surgery
Patient Written And Informed Consent. 
 
ExclusionCriteria 
Details  Allergy to Study Drug
ASA Grade III/IV. 
 
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 Analgesic effect postoperatively between Tramadol and Transdermal Buprenorphine patch in Nephrectomy patients.  5-7 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/09/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - NO
Brief Summary  

Postoperative pain is a major concern for patients undergoing Nephrectomy surgery. Pain can be associated with adverse physiological and psychological effects hampering the normal recovery process. Preventive analgesia, initiated before the surgical procedure, can theoretically reduce pain sensitization, but multiple clinical studies have failed to demonstrate convincing clinical benefit.

Buprenorphine, a derivative of the opium alkaloid thebaine, is a more potent and longer lasting analgesic. Its dissociation from opioid receptor binding is slow which probably accounts for its longer duration of action. The lack of delta receptor agonist activity may be responsible for the observation that buprenorphine is less likely to induce tolerance on chronic use.

Buprenorphine is used clinically for the treatment of moderate-to-severe pain, including perioperative analgesia. A transdermal patch formulation of buprenorphine has recently been introduced in the Indian market. Although expensive, this mode of delivery has several potential benefits over oral and parenteral administration. These include noninvasive dosing, better absorption, lack of first-pass metabolism, and steady plasma concentration. The buprenorphine patch releases the analgesic steadily over 7 days and has been successfully used to treat a variety of chronic pain conditions. However, there is limited clinical experience of its utility in postoperative pain.  

 

 

Tramadol is a centrally acting analgesic with weak opioid agonist. Its safety is well established by the fact that the clinically relevant respiratory depression is not seen with tramadol and it has low dependence and abuse potential. All these properties make tramadol as the ideal drug for the management of post-operative pain. Hence, tramadol is one of the most commonly used analgesics in post-operative period. Tramadol has good bioavailability (70%–90%); hence, it has been used for providing post-operative analgesia. It should be used cautiously in patients with renal failure due to risk of accumulation.

 
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