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CTRI Number  CTRI/2025/10/095722 [Registered on: 08/10/2025] Trial Registered Prospectively
Last Modified On: 06/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Calculating minimum effective dose of local anaesthetic mixture for arm surgeries using nerve block  
Scientific Title of Study   Minimum effective volume of 0.5 percent Ropivacaine and 2 percent Lignocaine mixture for ultrasound guided Retroclavicular Brachial Plexus Block: A Prospective Dose Finding Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Heena Garg 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Anaesthesiology, AIIMS, Ansari nagar, New Delhi 110029

South
DELHI
110029
India 
Phone  9464533877  
Fax    
Email  gargheena11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Heena Garg 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Anaesthesiology, AIIMS, Ansari nagar, New Delhi 110029


DELHI
110029
India 
Phone  9464533877  
Fax    
Email  gargheena11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Heena Garg 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Anaesthesiology, AIIMS, Ansari nagar, New Delhi 110029


DELHI
110029
India 
Phone  9464533877  
Fax    
Email  gargheena11@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, AIIMS, Ansari nagar, New Delhi 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Department of Anaesthesiology, AIIMS, Ansari nagar, New Delhi 110029 
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 
heena garg  AIIMS  Department of Anaesthesiology, AIIMS, Ansari nagar, New Delhi 110029
South
DELHI 		 9464533877

gargheena11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Ropivacaine and Lignocaine mixture  0.5% Ropivacaine and 2% Lignocaine mixture in 3:2 ratio given at the time of block after taking the patient in the operation theatre. around 24 hours in the perioperative period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA Physical Status I or II, Consent for regional anaesthesia and participation, Elective surgery of the upper limb, BMI between 18–30 kg/m²
 
 
ExclusionCriteria 
Details  coagulopathy, allergy to local anaesthetics, pregnancy, pre existing neuropathy  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The calculation of minimum effective volume (MEV50 and MEV95) of a mixture of 0.5% ropivacaine and 2% lignocaine for achieving a successful sensory and motor block at 30 minutes.   The calculation of minimum effective volume (MEV50 and MEV95) of a mixture of 0.5% ropivacaine and 2% lignocaine for achieving a successful sensory and motor block at 30 minutes.  
 
Secondary Outcome  
Outcome  TimePoints 
1. Block performance time (time from the first insertion of the blocking needle to its removal)
2. Block onset time ( time required for a composite score of 14 points)
3. Duration of sensory (time from the injection of LA to the time the patient recovers full sensation of the upper limb)
4. Duration of motor blockade (time from injection of LA to the time the patient recovers full function of the arm)
5. Any perioperative complications (e.g., local anesthetic systemic toxicity, vascular puncture)
6. Need for conversion to GA
 		 from start of anaesthesia till 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   18/10/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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 - NO
Brief Summary   Combining faster onset lignocaine with other slower onset agents such as bupivacaine, levobupivacaine and ropivacaine can hasten the onset of the block. The minimum effective volume (MEV) and concentration of local anesthetics are key to maximizing the quality and safety of nerve blocks while minimizing risks such as local anesthetic systemic toxicity. Dose finding studies have been done using 0.5% bupivacaine and 0.5% ropivacaine in Retroclavicular Block (RCB). A clinically effective dose of combination of local anaesthetic (LA) for achieving an adequate block with retroclavicular approach is lacking. This study seeks to determine the MEV50 and MEV95 of a 3:2 mixture of 0.5% ropivacaine and 2% lignocaine in adults undergoing upper limb surgeries under the retroclavicular approach of infraclavicular block. 
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