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CTRI Number  CTRI/2025/10/096144 [Registered on: 16/10/2025] Trial Registered Prospectively
Last Modified On: 16/10/2025
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 Costoclavicular Block and Interscalene Block for Pain Relief After Shoulder Arthroscopy Done Under General Anaesthesia” 
Scientific Title of Study   Comparison Of Efficacy Of Costoclavicular Block With Interscalene Block For Postoperative Analgesia In Patients Undergoing Arthroscopic Shoulder Surgery Under General Anaesthesi 
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 Jitendra Yadav 
Designation  Post Graduation Student 
Affiliation  Vardhman Mahavir Medical College And Safdarjung Hospital 
Address  Department of anaesthesia VMMC & SJH Campus Ring Rd Safdarjung Campus Ansari Nagar West New Delhi Delhi 110029

South
DELHI
110029
India 
Phone  9599534885  
Fax    
Email  jy232021@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suman Saini 
Designation  Director Professor 
Affiliation  Vardhman Mahavir Medical College And Safdarjung Hospital 
Address  Department of anaesthesia VMMC & SJH Campus Ring Rd Safdarjung Campus Ansari Nagar West New Delhi Delhi 110029

South
DELHI
110029
India 
Phone  9891228793  
Fax    
Email  drsainisumannony@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suman Saini 
Designation  Director Professor 
Affiliation  Vardhman Mahavir Medical College And Safdarjung Hospital 
Address  Department of anaesthesia VMMC & SJH Campus Ring Rd Safdarjung Campus Ansari Nagar West New Delhi Delhi 110029

South
DELHI
110029
India 
Phone  9891228793  
Fax    
Email  drsainisumannony@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia and intensive care vardhman mahavir medical college and safdarjung hospital 
 
Primary Sponsor  
Name  Vmmc and safdarjung hospital 
Address  Vmmc and safdarjung hospitalAnsari Nagar East, near to AIIMS Metro Station, New Delhi, 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 jitendra yadav  vmmc and safdarjung hospital  Department of anaesthesia Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029
South
DELHI 		 9599534885

jy232021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee 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: M751||Rotator cuff tear or rupture, notspecified as traumatic, (2) ICD-10 Condition: M759||Shoulder lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  costoclavicular block   It is a procedure intervention in regional anaesthesia. costoclavicular block will be done under the ultrasound guided 20 ml of .5% of ropivacaine and 4 mg of dexamethasone will be injected.it is compared with interscalene block 
Comparator Agent  Interscalene block  It is a procedure intervention in regional anaesthesia. interscalene block will be done under ultrasound guidance,10ml of .5% ropvicane and 4 mg of dexamethasone will be injected.it is compared wit costoclavicular block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients 18-65 years of age belonging to the American Society of Anesthesiologists (ASA) physical status I or II scheduled to undergo unilateral arthroscopic shoulder surgery. 
 
ExclusionCriteria 
Details  Patients with
1. Known coagulopathies or on anticoagulant therapy, infection at the proposed site of block and known allergies to the effect of local anaesthetics
2. Known preexisting Neurological deficit in the upper limbs
3. Known preexisting lung diseases or hemidiaphragmatic dysfunction
4. Pregnant Women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic efficacy of costoclavicular block and interscalene block in patients undergoing arthroscopic shoulder surgery under general anaesthesia,as measured by the numeric range scale at 1 hour rest  At base line and 1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
To compare NRS at 0 4 8 and 24 hours postoperatively at rest and cumulative NRS score at 24 hrs at rest to asses the time of frist rescue analgesia and to compare total amount of rescue analgesia consumption in each group  18 month 
To assess the incidence of hemidiaphragmatic paresis using USG guided diaphragmatic excursion and pulmonary function test (FVC FEV1 andPFR) using CONTEC spirometer CMS SP100 at baseline and 30 minutes post block and 1 hour in PACU  18 month 
To assess the block characteristics like time of performance of block and onset of sensory and motor block  18 month 
To assess total intra operative fentanyl consumption and hemodynamic parameters like HR MAP and spo2  18 month 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   27/10/2025 
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  

This prospective randomized controlled study compares the effectiveness of costoclavicular block and interscalene block for post operative pain control in adult patients undergoing arthroscopic shoulder surgery under general anaesthesia                                             


The primary objective is to compare the duration of analgesia provided by each block as measured by numeric rating scale pain scores 

Secondary objectives include assessing block characteristics such as onset and duration,measuring total opioid use in the frist 24 hours after surgery,monitoring hemodynamic parameters andcomplications,evaluating ease of performance and patient satisfaction.


findings from this study will help inform the choice of regional anaesthesia technique for shoulder surgery,with the aim of improving pain management and reduce opioid use.

 
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