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CTRI Number  CTRI/2025/03/081561 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 01/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Compare the anaesthetic efficay of bupivacaine and levobupivacaine in brachial plexus block in upper limb surgeries. 
Scientific Title of Study   A randomised controlled trial comparing anaesthetic efficacy of 0.5 percentage Bupivacaine and 0.5 percentage Levobupivacaine in supra-clavicular brachial plexus block with peripheral nerve stimulator in upper limb surgeries. 
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 Manisha 
Designation  Post Graduate Student 
Affiliation  Maharaja Agrasen Medical College and Hospital , Agroha , Hisar 
Address  Operation Theater Complex Department of Anaesthesia Maharaja Agrasen Medical College and Hospital , Agroha , Hisar Haryana India

Hisar
HARYANA
125047
India 
Phone  8570008304  
Fax    
Email  manisharathi2303@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumitra Kanojiya 
Designation  Professor ,Department of Anaesthesia 
Affiliation  Maharaja Agrasen Medical College and Hospital 
Address  Operation Theater Complex Department of Anaesthesia Maharaja Agrasen Medical College and Hospital, Agroha, Hisar Haryana India

Hisar
HARYANA
125047
India 
Phone  8307994393  
Fax    
Email  drsumitrakanojiya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumitra Kanojiya 
Designation  Professor ,Department of Anaesthesia 
Affiliation  Maharaja Agrasen Medical College and Hospital 
Address  Operation Theater Complex Department of Anaesthesia Maharaja Agrasen Medical College and Hospital, Agroha, Hisar Haryana India

Hisar
HARYANA
125047
India 
Phone  8307994393  
Fax    
Email  drsumitrakanojiya@gmail.com  
 
Source of Monetary or Material Support  
Maharaja Agrasen Medical college, Agroha, Hisar,India 125047 
 
Primary Sponsor  
Name  Manisha 
Address  Maharaja Agrasen Medical Collegfe , Agroha , Hisar 
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 Manisha  Maharaja Agrasen Medical college  Operation theater Complex Department of Anaesthesia
Hisar
HARYANA 		 8570008304

manisharathi2303@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Human Research, Maharaja Agrasen Medical Colleg, Agroha, Hisar (Haryana)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ASA 1 and 2 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Levobupivacaine  30ml of 0.5 percentage levobupivacaine  
Intervention  supraclavicular brachial plexus block   30ml of 0.5 percentage bupivacaine and levobupivacaine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex, aged 18–60 years, belonging to American Society of
Anesthesiologists(ASA) physical status class I and II willing to participate in the study 
 
ExclusionCriteria 
Details  1. Who refuses to give consent.
2. With severe cardiac, renal, endocrine, pulmonary disease.
3. Who are allergic to study drugs.
4. Who is having a local site infection.
5. With hemi-diaphragmatic paralysis on opposite side of surgery
6. With any psychological disorder who would interfere with assessment of pain.
7. With a history of brachial plexus injury.
8. With bilateral upper limb surgery and fracture.
9. With a heart rate less than 60/minute 
 
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 
1. Onset and duration of Sensory block
2. Onset and duration of motor block 		 Onset of sensory and motor blockade will be monitored every two minutes for the first 20
minutes and then every five minutes till 30 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Hemodynamic parameters including HR, SBP, DBP
2. Complications include hypotension, bradycardia, pneumothorax,nausea, vomiting and
pruritus.
3. Duration of postoperative analgesia.
4. Time for first rescue analgesia. 		 0 minute
2 minutes
5 minutes
10 minutes
and assess time period upto 24 hours  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   12/03/2025 
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="3"
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 - NO
Brief Summary   This study has been planned with an aim to compare the effectiveness of bupivacaine and levobupivacaine in supraclavicular brachial plexus block and to compare onset and duration of sensory ,motor blockade,duration of analgesia and hemodynamic parameters among patients undergoing upper limb surgeries. 
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