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CTRI Number  CTRI/2025/07/091712 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two ways of giving block injections for arm surgery. A study on timing and effectiveness. 
Scientific Title of Study   Effect of mixture versus sequential injections of lignocaine and bupivacaine on block characteristics for supraclavicular brachial plexus nerve block in patients undergoing upper limb surgery. A randomised clinical 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  Dr Dakshatha Cr 
Designation  Post graduate student  
Affiliation  Bangalore medical college and research institute  
Address  Department of anaesthesiology Bangalore medical college and research institute Fort, Krishna Rajendra Road, Kalasipalya, Bengaluru, Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9742418780  
Fax    
Email  dakshathacr99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudheesh K 
Designation  Professor  
Affiliation  Bangalore medical college and research institute  
Address  Department of anaesthesiology Bangalore medical college and research institute Fort, Krishna Rajendra Road, Kalasipalya, Bengaluru, Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9900134694  
Fax    
Email  drsudhi@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sudheesh K 
Designation  Professor  
Affiliation  Bangalore medical college and research institute  
Address  Department of anaesthesiology Bangalore medical college and research institute Fort, Krishna Rajendra Road, Kalasipalya, Bengaluru, Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9900134694  
Fax    
Email  drsudhi@rediffmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Dakshatha Cr 
Address  Fort, Krishna Rajendra road,, Kalasipalya, Bengaluru, Karnataka 560002 
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 Sudheesh K  Bangalore medical college and research institute   Department of anaesthesiology Bangalore medical college and research institute Fort, Krishna Rajendra Road, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA 		 9900134694

drsudhi@reddifmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore medical college and research institute   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 
Intervention  Lignocaine and bupivacaine mixture  In mixture, 24ml of the mixture of both 10 ml of 2% lignocaine with adrenaline and 14ml of 0.5% bupivacaine will be directly deposited. 
Comparator Agent  Sequential injections of lignocaine and bupivacaine  In sequential, 10ml of 2% lignocaine with adrenaline will be injected first followed by an injection of 14ml of 0.5% bupivacaine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Under ASA grade 1 and 2, weighing 60kg and above, willing to give informed written consent, planned for unilateral upper limb surgery. 
 
ExclusionCriteria 
Details  Coagulation or bleeding disorders, Local site infection ,Any nerve injury or neuropraxia or paralysis, History of allergy or anaphylaxis to bupivacaine or lignocaine, Pregnant and lactating females. 
 
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 
To assess the duration of sensory block   24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the onset of sensory and motor block. To assess the duration of motor block. To assess the duration of analgesia. To determine the percentage of patients having block in all four nerve areas by 15 min.  24 hours 
 
Target Sample Size   Total Sample Size="152"
Sample Size from India="152" 
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)   15/09/2025 
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 Yet Recruiting 
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 - NO
Brief Summary   This study is a randomised, double blind, parallel group, trail comparing the effect of mixture versus sequential injections of 2% lignocaine with adrenaline and 0.5% bupivacaine for supraclavicular brachial plexus nerve block in 152 patients undergoing upper limb surgery. The primary outcome measures will be the duration of sensory block. The secondary outcomes will be onset of sensory and motor block, the duration of motor block, the duration of analgesia, the percentage of patients having block in all four nerve areas by 15 min. 
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