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CTRI Number  CTRI/2025/12/098250 [Registered on: 01/12/2025] Trial Registered Prospectively
Last Modified On: 29/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two approaches to block nerves that supply the upper limbs for surgical interventions. 
Scientific Title of Study   A Comparative Evaluation Of Ultrasound Guided Costoclavicular Brachial Plexus Block Versus Axillary Brachial Plexus Block For Upper Limb Surgery - A Prospective Randomised Clinical 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  DR Mohd Asim 
Designation  Junior Resident Doctor  
Affiliation  Jawaharlal Nehru Medical College, Aligarh Muslim University. 
Address  Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

Aligarh
UTTAR PRADESH
202002
India 
Phone  7017694493  
Fax    
Email  asimkhan98239@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Qazi Ehsan Ali 
Designation  Professor  
Affiliation  Jawaharlal Nehru Medical College, Aligarh Muslim University. 
Address  Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

Aligarh
UTTAR PRADESH
202002
India 
Phone  7417701769  
Fax    
Email  qaziehsanali@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Qazi Ehsan Ali 
Designation  Professor  
Affiliation  Jawaharlal Nehru Medical College, Aligarh Muslim University. 
Address  Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

Aligarh
UTTAR PRADESH
202002
India 
Phone  7417701769  
Fax    
Email  qaziehsanali@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India, 202002. 
 
Primary Sponsor  
Name  Department Of Anaesthesiology And Critical Care 
Address  Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India, 202002. 
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 Mohd Asim  Jawaharlal Nehru Medical College And Hospital   Department of Anaesthesiology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India, 202002.
Aligarh
UTTAR PRADESH 		 7017694493

asimkhan98239@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL 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  Axillary Brachial Plexus Block  30 ml of the local anaesthetic mixture ( 10 ml of 2% lignocaine plus 20 ml of 0.5% of bupivacaine) will be infiltrated around cords of brachial plexus slowy by the ultrasound guidance through axillary approach once only. 
Intervention  Costoclavicular Brachial Plexus Block  30 ml of the local anaesthetic mixture ( 10 ml of 2% lignocaine plus 20 ml of 0.5% of bupivacaine) will be infiltrated around cords of brachial plexus slowly in the costoclavicular space by ultrasound guidance once only. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Grade 1 and 2
BMI 18.5 to 24.9 
 
ExclusionCriteria 
Details  ASA Grade 3 and 4
Coagulation Abnormalities
Infections at site
Liver/ Renal/ Heart diseases
Pregnancy
Neurological deficit  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To Compare The Efficacy Of Duration Of Analgesia In Costoclavicular Brachial Plexus Block Versus Axillary Brachial Plexus Block.  From the onset until the effect wears off. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the onset time of effective sensory & motor blockade in costoclavicular versus axillary brachial plexus block.  Time taken from giving the block, with assessments every 5 minutes, until adequate sensory & motor blockade occurs. 
To compare costoclavicular versus axillary brachial plexus block in terms of intensity of pain, if experienced by the patient using numerical rating scale.  Pain assessment using numerical rating scale every 5 minutes until surgical readiness, then every 30 minutes during intraoperative period, & then every 1 hour in the postoperative period. 
To compare costoclavicular versus axillary brachial plexus block for the demand of additional analgesia/sedatives if needed.  Time taken for first analgesic/sedative demand & total 24-hour analgesic requirement if needed. 
To compare the incidence of complications in costoclavicular versus axillary brachial plexus block.  Assessment of patient every 30 minutes intraoperatively & every 1 hour in the post-anaesthesia care unit for dyspnea, Horner’s syndrome, hemidiaphragmatic paralysis, local anaesthetic toxicity, & pneumothorax.
 
 
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 2/ Phase 3 
Date of First Enrollment (India)   10/12/2025 
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="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  
1. To compare costoclavicular vs axillary brachial plexus block for the onset of effective sensory and motor blockade.

 

2. To compare costoclavicular vs axillary brachial plexus block for the demand of additional analgesics/sedatives (time for first analgesic/sedative demand and total 24-hour analgesic requirement) if needed.

 

3. To compare costoclavicular vs axillary brachial plexus block in terms of intensity of pain, if experienced by the patient using NRS (Numerical Rating Scale)

 

4. To compare the incidence of complications – Dyspnea, Horner syndrome, hemi-diaphragmatic paralysis (after 30 min and in post anesthesia care unit), local anesthesia toxicity, pneumothorax incidence.
 
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