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CTRI Number  CTRI/2024/03/063857 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To compare the pain score after operation in patients undergoing laminectomy surgeries by spraying buprenorphine and saline in epidural space 
Scientific Title of Study   A RANDOMIZED DOUBLE BLINDED COMPARITIVE STUDY OF INSTILLATION OF BUPRENORPHINE VS PLACEBO IN EPIDURAL SPACE FOR POSTOPERATIVE ANALGESIA IN POST LAMINECTOMY PATIENTS 
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 Yoganarasimha N 
Designation  Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Anaesthesiology, BGS Global Institute of Medical Sciences, Uttarahalli Main Road, Kengeri, Bangalore

Bangalore
KARNATAKA
560060
India 
Phone  9845365348  
Fax    
Email  yogabmc98@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandana P 
Designation  Assistant Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Anaesthesiology, BGS Global Institute of Medical Sciences, Uttarahalli Main Road, Kengeri, Bangalore

Bangalore
KARNATAKA
560060
India 
Phone  9980933692  
Fax    
Email  drchandana.chandana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amrutha H A 
Designation  Post-graduate 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Anaesthesiology, BGS Global Institute of Medical Sciences, Uttarahalli Main Road, Kengeri, Bangalore

Bangalore
KARNATAKA
560060
India 
Phone  9738556636  
Fax    
Email  haamrutha21@gmail.com  
 
Source of Monetary or Material Support  
BGS Global Institute of Medical Sciences, Uttarahalli main road, Kengeri, Bangalore 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  BGS Global Institute of Medical Sciences, Uttarahalli Main Road, Kengeri, Bangalore 
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 Yoganarasimha N  BGS Global Institute of Medical Sciences  Professor, Department of anaesthesia, BGS Global Institute of Medical Sciences, Uttarahalli main road, Kengeri, Bangalore
Bangalore
KARNATAKA 		 9845365348

yogabmc98@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BGS Global 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: G952||Other and unspecified cord compression,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj Buprenorphine  300mcg, Diluted to 10ml Instilled into epidural space, 3 mins 
Comparator Agent  Placebo (Normal saline)  10ml, instilled into epidural space, 3 mins 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to give informed and written consent
ASA physical status I & II
Patients with body weight 50-80kgs
 
 
ExclusionCriteria 
Details  ASA physical status III and above.
Patients who have known hypersensitivity to the study drugs
Patients with history of neuromuscular disease
Patients with history of substance abuse
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Pain by Numerical pain rating scale
 		 1st, 2nd, 3rd, 4th, 5th, 6th, 12th, 18th and 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
Pulse Rate
Mean Arterial Pressure
Respiratory Rate
SpO2
 		 1st, 2nd, 3rd, 4th, 5th, 6th, 12th, 18th and 24 hours  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/03/2024 
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="0"
Months="6"
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
  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

  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) - 

  6. For how long will this data be available start date provided 01-04-2024 and end date provided 21-07-2084?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Immediate postoperative pain relief after surgery can significantly affect the outcome of surgical procedures and operative morbidity. Parenteral opioids are the mainstay of treatment for postoperative pain after laminectomy. But these are usually given with large time lapses which cause fluctuations in clinical effect. 

The epidural injection of opioids has proven to be effective and has a longer duration of action in relieving postoperative pain. Postoperative pain management for spinal surgery with epidural infusion of morphine and fentanyl has been widely reported. Buprenorphine, because it is more potent and more lipid-soluble and has a longer duration of action, is said to have advantages over morphine for epidural use in postoperative pain relief.

 
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