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CTRI Number  CTRI/2020/03/024013 [Registered on: 17/03/2020] Trial Registered Prospectively
Last Modified On: 06/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing mixture of local anaesthetic agents lignocaine and ropivacaine versus sequential lignocaine followed by ropivacaine in patients undergoing surgery on hands and arms under regional anaesthesia. 
Scientific Title of Study   A randomized double blinded study comparing block characteristics of mixture of lignocaine and ropivacaine versus sequential lignocaine followed by ropivacaine in patients undergoing upper limb surgery under supra-clavicular brachial plexus nerve block.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mridul Dhar 
Designation  Assistant Professor, Anaesthesiology 
Affiliation  AIIMS, Rishikesh 
Address  Veerbhadra Road, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9717778374  
Fax    
Email  mriduldhar@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mridul Dhar 
Designation  Assistant Professor, Anaesthesiology 
Affiliation  AIIMS, Rishikesh 
Address  Veerbhadra Road, Rishikesh


UTTARANCHAL
249203
India 
Phone  9717778374  
Fax    
Email  mriduldhar@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Mridul Dhar 
Designation  Assistant Professor, Anaesthesiology 
Affiliation  AIIMS, Rishikesh 
Address  Veerbhadra Road, Rishikesh


UTTARANCHAL
249203
India 
Phone  9717778374  
Fax    
Email  mriduldhar@hotmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Mridul Dhar 
Address  Department of Anaesthesiology, AIIMS, Rishikesh 
Type of Sponsor  Other [Self] 
 
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 Mridul Dhar  AIIMS Rishikesh, Department of Anaesthesiology  Veerbhadra Road, Rishikesh
Dehradun
UTTARANCHAL 		 9717778374

mriduldhar@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethics committee, AIIMS Rishikesh  Approved 
Institutional ethics committee, AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lignocaine and Ropivacaine mixture  Technique of Mixture of Lignocaine and Ropivacaine in USG guided supraclavicular brachial plexus block for upper limb surgery 
Intervention  Sequential Lignocaine followed by Ropivacaine  Sequential Lignocaine followed by Ropivacaine in USG guided supraclavicular brachial plexus block for upper limb surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Weighing more than 60 kg, planned for unilateral upper limb surgery 
 
ExclusionCriteria 
Details  Patient refusal, coagulation or bleeding disorders, local site infection, any nerve injury/ neuropraxia/ paralysis, history of allergy or anaphylaxis to ropivacaine or lignocaine, pregnant females and block failure due to technical reasons. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients with complete sensory block in all 4- nerve areas (musculo-cutaneous, median, radial, ulnar) at 10 minutes post injection.  Percentage of patients with complete sensory block in all 4- nerve areas (musculo-cutaneous, median, radial, ulnar) at 10 minutes post injection. 
 
Secondary Outcome  
Outcome  TimePoints 
Time to onset of first sensory block, time to onset of complete sensory block, time to complete motor block, duration of analgesia, procedure time, block failures, duration of sensory block, duration of motor block, and complication rates ( last three reading will be observed in post-anaesthesia care unit every one hour and in ward every 2 hours by in-charge nurse or resident.   Time to onset of first sensory block, time to onset of complete sensory block, time to complete motor block, duration of analgesia, procedure time, block failures, duration of sensory block, duration of motor block, and complication rates ( last three reading will be observed in post-anaesthesia care unit every one hour and in ward every 2 hours by in-charge nurse or resident.  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/03/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Studies have been conducted on use of ropivacaine, bupivacaine and lignocaine in various combinations in various nerve blocks and neuraxial blocks. There is no clear consensus on appropriate use of mixtures of these agents specially in brachial plexus nerve blocks. Ropivacaine is an established safer, equally efficacious alternative to bupivacaine. We intend to compare use of a short acting drug lignocaine and long acting drug Ropivacaine as a mixture versus undiluted sequential injections on block characteristics of ultrasound guided nerve block for upper limb surgeries. 
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