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CTRI Number  CTRI/2025/03/082476 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Adult patients undergoing Ultrasonography guided block for upper limb surgeries, comparing 20ml 0.5% Levobupivacaine with 90mcg Buprenorphine and 20ml 0.5% Ropivacaine with 90mcg Buprenorphine in the terms of duration of postoperative pain relief. 
Scientific Title of Study   A Randomised double-blind controlled trial to compare the block efficacy, postoperative analgesia requirements and safety profile between 0.5 percent Ropivacaine with 90mcg Buprenorphine and 0.5 percent Levobupivacaine with 90mcg Buprenorphine in adult patients undergoing upper limb orthopaedic surgeries with ultrasound guided Supraclavicular Brachial Plexus Block anaesthesia 
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 KABILAN R 
Designation  Junior Resident, Dept. of Anaesthesia 
Affiliation  MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES,SEVAGRAM,WARDHA 
Address  Room No:27, Department of Anaesthesia, Main Operation Theatre, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, MAHARASHTRA, India 442102

Wardha
MAHARASHTRA
442102
India 
Phone  9790048314  
Fax    
Email  kabilrathna95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr DHIRAJ BHANDARI 
Designation  Professor, Dept. of Anaesthesia 
Affiliation  MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES,SEVAGRAM,WARDHA 
Address  Department of Anaesthesia, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha. MAHARASHTRA, India 442102

Wardha
MAHARASHTRA
442102
India 
Phone  9970195086  
Fax    
Email  dhirajbhandari@mgims.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Kabilan R 
Designation  Junior Resident, Dept. of Anaesthesia 
Affiliation  Mahatma Gandhi institute of medical sciences, Sevagram, Wardha 
Address  Jawaharlal Nehru Boys Hostel, Room No- Utility 2, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, MAHARASHTRA, India 442102

Wardha
MAHARASHTRA
442102
India 
Phone  9790048314  
Fax    
Email  kabilrathna95@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra, India. Pincode 442102. 
 
Primary Sponsor  
Name  Mahatma Gandhi Institute of Medical Sciences 
Address  Sevagram, Wardha, Maharashtra, India. Pincode 442102. 
Type of Sponsor  Research institution and hospital 
 
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 Kabilan R  Mahatma Gandhi Institute of Medical Sciences   Main Operation Theatre, First floor, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra, India. Pincode 442102.
Wardha
MAHARASHTRA 		 9790048314

kabilrathna95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, MGIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S52||Fracture of forearm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% Ropivacaine with 90mcg Buprenorphine  Supraclavicular Brachial Plexus Block will be given to adult patients undergoing upperlimb orthopaedic surgeries using 0.5% Ropivacaine ie.100mg 20ml with 90mcg Buprenorphine as supraclavicular brachial plexus block. Total procedure duration- 20 minutes. 
Intervention  Supraclavicular Brachial Plexus Block using Levobupivacaine  Supraclavicular Brachial Plexus Block will be given to adult patients undergoing upperlimb orthopaedic surgeries using 0.5% Levobupivacaine 20ml ie. 100mg with 90mcg Buprenorphine as supraclavicular brachial plexus block. Total procedure duration- 20 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. American society of Anaesthesiologists (ASA) physical status I/II patients
2. Patients weight more than 40 kg
3. Patients scheduled for emergency, semi emergency or elective upper limb orthopaedic upper limb (elbow, forearm and hand) surgery.
4. Patients willing to take part in the study.
Haemodynamically stable patient with HR more than 60/min, MAP more than 60mmHg 
 
ExclusionCriteria 
Details  1. Patients refusing to voluntarily participate in the study
2. Pre-existing peripheral neuropathy of upper limb
3. Patients with Bleeding disorders
4. Patients with infection at injection site
5. Patients with pneumothorax
6. Patients on adrenoreceptor agonist or antagonist therapy
7. History of severe cardiac disease
8. History of respiratory disease
9. History of hepatic disease / renal disease
10. Pregnancy
11. Known hypersensitivity to the study drugs
 
 
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 
Time required for first rescue analgesia  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Haemodynamic stability, sensory and motor block  3 hours 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   28/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  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 - Proposals should be directed to [kabilrathna95@gmail.com].

  6. For how long will this data be available start date provided 06-05-2024 and end date provided 06-05-2029?
    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 to evaluate and compare the efficacy and safety profile between 20ml 0.5% Levobupivacaine with 90mcg Buprenorphine and 20ml 0.5% Ropivacaine with 90mcg Buprenorphine when used in Ultrasonography (USG) guided supraclavicular block in adult patients undergoing upper limb orthopaedic surgeries. There is however paucity of data comparing Buprenorphine at mentioned doses directly between Levobupivacaine and Ropivacaine, especially from Indian sub-continent and therefore this study is planned to research the same.

 
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