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CTRI Number  CTRI/2025/11/096831 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 01/11/2025
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   Comparison of Two Ultrasound-Guided Brachial Plexus Block Techniques for Upper Limb Surgeries in Children  
Scientific Title of Study   Comparison of performance of ultrasound guided costoclavicular and supraclavicular brachial plexus blocks in paediatric patients undergoing 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  Amrita Chatterjee  
Designation  Postgraduate resident  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesiology and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital

South
DELHI
110029
India 
Phone  9674220182  
Fax    
Email  chatterjeeamrita34@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Abhishek Verma 
Designation  Professor  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesiology and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital

South
DELHI
110029
India 
Phone  9999894372  
Fax    
Email  abhishek.verma.mamc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Abhishek Verma 
Designation  Professor  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesiology and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital

South
DELHI
110029
India 
Phone  9999894372  
Fax    
Email  abhishek.verma.mamc@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi 110029 
 
Primary Sponsor  
Name  Amrita Chatterjee  
Address  Depart of Anaesthesiology and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi- 110029 
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 Amrita Chatterjee   Vardhman Mahavir Medical College and Safdarjung Hospital   Department of Anaesthesiology and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi- 110029
South
DELHI 
9674220182

chatterjeeamrita34@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of VMMC and Safdarjung Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Costoclavicular block  Ultrasound-guided costoclavicular block using Inj. Ropicpvacaine 0.5% at baseline during administration of block. 
Comparator Agent  Supraclavicular block   Ultrasound-guided supraclavicular block using Inj. Ropivacaine 0.5% at baseline during administration of block.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  ASA status I and II, scheduled to undergo upper limb surgeries. 
 
ExclusionCriteria 
Details  1. Infection at needle insertion site.
2. Coagulopathy or bleeding disorders.
3. Known allergy to local anaesthetics.
4. Pre-existing neurological disorders. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the costoclavicular and supraclavicular brachial plexus blocks in terms of performance time.  To compare the costoclavicular and supraclavicular brachial plexus blocks in terms of performance time at baseline during administration of block. 
 
Secondary Outcome  
Outcome  TimePoints 
Assess block success rate (surgical anaesthesia without rescue analgesia)  At the time of surgical incision. 
Comparing postoperative pain score - CHEOPS score   2, 4, 6, 24 hours after surgery 
To compare diaphragmatic excursion.  At baseline and in immediate post-operative  
To assess the time of first rescue analgesia administration.   Time when first rescue analgesia was given. 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   15/11/2025 
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="6"
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  
Title:
Comparison of Performance of Ultrasound-Guided Costoclavicular and Supraclavicular Brachial Plexus Blocks in Paediatric Patients Undergoing Upper Limb Surgeries

Candidate:
Dr. Amrita Chatterjee
Postgraduate Resident, Department of Anaesthesia and Intensive Care
Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi

Supervisor: Dr. Abhishek Verma, MD
Professor, Department of Anaesthesia and Intensive Care

Background and Rationale:
Ultrasound-guided regional anaesthesia provides superior peri-operative analgesia and reduces opioid use in paediatric upper-limb surgeries. The supraclavicular brachial plexus block (SCB), though widely practiced, carries risks such as pneumothorax and phrenic nerve palsy. The costoclavicular brachial plexus block (CCB), a novel infraclavicular approach, offers potential advantages of safety, faster performance, and reliable spread of local anaesthetic due to the compact arrangement of cords. However, evidence in the paediatric population remains limited, warranting comparative evaluation.

Research Question:
Is the ultrasound-guided costoclavicular block comparable to the supraclavicular block in terms of performance time in paediatric patients undergoing upper-limb surgery?

Hypothesis:
The ultrasound-guided costoclavicular block is comparable to the supraclavicular block regarding block performance time.

Aim:
To compare the costoclavicular and supraclavicular approaches of brachial plexus block with respect to block performance in paediatric upper-limb surgeries.

Objectives:
Primary: Compare the performance time between costoclavicular and supraclavicular blocks.

Secondary:

Assess block success rate.

Compare postoperative pain using the CHEOPS score at 2, 4, 6, and 24 hours.

Evaluate diaphragmatic excursion pre- and post-operatively.

Record time to first rescue analgesia.

Study Design:
Type: Prospective, randomized interventional study

Setting: Department of Anaesthesia and Intensive Care, VMMC & Safdarjung Hospital, New Delhi

Duration: 18 months

Sample Size: 84 children (42 per group), calculated with 80% power and 5% significance level (based on Guzel et al., 2023).

Methodology:
Children aged 1–8 years, ASA physical status I–II, undergoing elective upper-limb surgery will be enrolled after parental consent and ethical clearance. Participants will be randomized using sealed opaque envelopes into two groups:

Group SCB: Supraclavicular approach

Group CCB: Costoclavicular approach

Blocks will be performed under ultrasound guidance following general anaesthesia, using 0.5% Ropivacaine (0.5 mL/kg). Imaging time, needling time, and total procedure time will be recorded. Pain will be assessed using CHEOPS, procedural ease and needle visibility by Likert scales, and diaphragmatic excursion by M-mode ultrasound.

Outcome Measures:
Parameter Assessment Tool / Unit
Performance Time Stopwatch (seconds)
Block Success Rate % requiring rescue analgesia
Post-operative Pain CHEOPS Score (4–13)
Diaphragmatic Excursion M-mode ultrasound
Procedural Ease 3- & 5-point Likert Scales
Statistical Analysis:
Data will be analysed using SPSS. Continuous variables will be expressed as mean ± SD and compared using t-test/ANOVA; categorical data using Chi-square/Fisher’s exact test. Correlation between variables will be analysed using Pearson/Spearman tests. Statistical significance will be set at p < 0.05.

Ethical Considerations:
The study will adhere to ICMR ethical guidelines. Institutional Ethics Committee approval and CTRI registration will be obtained. No additional financial or procedural burden will be placed on participants. Parental information sheets and informed consent forms are included in English and Hindi.

Summary:
This study aims to determine whether the costoclavicular block, a newer ultrasound-guided technique, provides a faster, safer, and equally effective alternative to the traditional supraclavicular block for providing peri-operative analgesia in paediatric upper-limb surgeries.
 
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