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CTRI Number  CTRI/2025/08/092271 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing Three types of numbing drugs combinations for arm Surgery using ultrasound guided nerve block: a Randomised study 
Scientific Title of Study   Comparison of efficacy of three different local anaesthetic mixtures for upper limb surgeries under usg guided supraclavicular brachial plexus block a randomised 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  AJJAYYA ABBIGERI HIREMAT  
Designation  Post graduate student  
Affiliation   
Address  Department of ANAESTHESIOLOGY Bmcrc Ballari 583104

Bellary
KARNATAKA
583104
India 
Phone  9964801858  
Fax    
Email  ajjayyaahm09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kiran Chand N 
Designation  Associate Professor  
Affiliation  BMC&RC Ballari 
Address  Department of Anaesthesiology, BMCRC, Ballari 583104

Bellary
KARNATAKA
583104
India 
Phone  9845857056  
Fax    
Email  nkiranchand@yahoo.com   
 
Details of Contact Person
Public Query  
Name  AJJAYYA ABBIGERI HIREMAT  
Designation  Post graduate student  
Affiliation  Bmcrc Ballari 
Address  Department of Anaesthesiology Bmcrc Ballari 583104

Bellary
KARNATAKA
583104
India 
Phone  9964801858  
Fax    
Email  ajjayyaahm09@gmail.com  
 
Source of Monetary or Material Support  
Ballari Medical College and Research Centre ,Ballari , Karnataka,India,583104 
 
Primary Sponsor  
Name  Ballari medical College and research centre  
Address  Ballari medical College and research centre , Contonment road ,Ballari ,583104 
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 AJJAYYA ABBIGERI HIREMAT   PMSSY Superspeciality hospital and Trauma Care Centre, BMC & RC, Ballari.  Department of Anaesthesiology,OT complex BMCRC, Ballari.583104
Bellary
KARNATAKA 		 9964801858

ajjayyaahm09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Ballari medical College & Research centre, Ballari   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 
Comparator Agent  10 ml 0.5 % bupivacaine and 10 ml of 2% lignocaine (5 mcg/ml adrenaline)   Under ultrasound guided supraclavicular brachial plexus block. 
Comparator Agent  Bupivacaine 0.5% 20ml  Under ultrasound guided supraclavicular brachial plexus block. 
Intervention  Lignoadrenaline 2% 20ml.   Under ultrasound guided supraclavicular brachial plexus block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients belonging to the age group 18-60 years with ASA grade I and grade II undergoing
elective or emergency procedure for upper limb bone surgeries at or below the elbow.
 
 
ExclusionCriteria 
Details  Patient refusal for the block. Patients refusing the block will be administered general
anaesthesia.
History of bleeding disorders
Local infection at the site of block
Pre-existing neurological deficit
Cardio-Respiratory compromise.
Known allergy to local anesthetic drug.
Patients in whom the supraclavicular sonoanatomy is not clear 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Onset of sensory and motor blockade  0,5,10,15,20,25,30,35,40minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of analgesia and anaesthesia  0,5,10,15,20,25,30,35,40minutes 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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 4 
Date of First Enrollment (India)   18/08/2025 
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="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 - All of the individual participant data collected during the trial, after de-identification.

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

  6. For how long will this data be available start date provided 21-07-2029 and end date provided 21-07-2040?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Combining local anesthetics (LAs) to achieve both rapid onset and prolonged duration has been practiced for over 50 years. While some studies have shown benefits—such as faster onset with a 40 mL mixture of mepivacaine and bupivacaine in infraclavicular blocks—others found no advantage at lower volumes (e.g., 30 mL in interscalene blocks). Advances in ultrasound-guided techniques have enabled effective brachial plexus blocks with lower volumes (10–20 mL), especially in the supraclavicular region. However, most studies focus on higher volumes. This study aims to evaluate the characteristics of a 20 mL mixture of local anesthetics for ultrasound-guided supraclavicular brachial plexus block. 
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