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CTRI Number  CTRI/2025/08/093572 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
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 Costoclavicular Block with Superior Trunk Block for pain relief in Adult Patients after Arthroscopic Shoulder Surgery under General Anaesthesia. 
Scientific Title of Study   Comparison of Costoclavicular Block with Superior Trunk Block for Postoperative Analgesia in Adult Patients undergoing Arthroscopic Shoulder Surgery under General Anaesthesia. 
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. Preethi M 
Designation  Postgraduate Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesia And Intensive Care, Vardhman Mahavir Medical College & Safdarjung Hospital, H693 H6W, NH 48, near AIIMS Hospital, Ansari Nagar West, New Delhi, Delhi 110029.

New Delhi
DELHI
110028
India 
Phone  7406685828  
Fax    
Email  minervamcg2406@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 and Intensive Care, Vardhman Mahavir Medical College & Safdarjung Hospital, H693 H6W, NH 48, near AIIMS Hospital, Ansari Nagar West, New Delhi, Delhi 110029.

New Delhi
DELHI
110028
India 
Phone  9891228793  
Fax    
Email  drsainisumannony@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Preethi M 
Designation  Postgraduate Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesia And Intensive Care, Vardhman Mahavir Medical College & Safdarjung Hospital. H693 H6W, NH 48, near AIIMS Hospital, Ansari Nagar West, New Delhi, Delhi 110029.

New Delhi
DELHI
110028
India 
Phone  7406685828  
Fax    
Email  minervamcg2406@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia And Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital  
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College & Safdarjung Hospital. H693 H6W, NH 48, near AIIMS Hospital, Ansari Nagar West, New Delhi, Delhi 110029. Department of  
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 Preethi M  Vardhman Mahavir Medical College and Safdarjung Hospital  Department of Anaesthesia and Intensive Care,Vardhman Mahavir Medical College & Safdarjung Hospital. H693 H6W, NH 48, near AIIMS Hospital, Ansari Nagar West, New Delhi, Delhi 110029.
New Delhi
DELHI 		 7406685828

minervamcg2406@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, VMMC & 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 procedural intervention in Regional Anaesthesia (Peripheral Nerve Block). Costoclavicular Block will be done under the Ultrasound Guidance, 20ml of 0.5% of Ropivacaine and 4mg of Dexamethasine will be injected. It is compared with Superior Trunk Block 
Comparator Agent  Superior Trunk Block  It is a procedural intervention in Regional Anaesthesia (Peripheral Nerva Block). Superior Trunk Block will be done under Ultrasound guidance, 10mL of 0.5% of Ropivacaine and 4mg of Dexamethasone will be injected. It is compared with Costoclavicular Block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients (18 to 65 years) of either sex of American Society of Anaesthesiologists (ASA) physical status I or II scheduled to undergo elective unilateral arthroscopic shoulder surgery and consenting to participate in the study will be included.  
 
ExclusionCriteria 
Details  1. Patients with history of allergy to any local anaesthetic and any contraindications to block (like patient with known case of coagulopathies or on anticoagulant therapy, infection at the proposed site of surgery).
2. Pre-existing Neurological Deficit in upper limb, hemidiaphragmatic dysfunction and lung diseases.
3. Inability to understand pain scale (Numeric Range scale).
4. Pregnant woman.
 
 
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 Superior Trunk Block in patient undergoing arthroscopic surgery under general anaesthesia, as measured by the Numeric Range Scale (NRS) pain score at 1 hour rest.  At baseline and at 1 hour  
 
Secondary Outcome  
Outcome  TimePoints 
To compare NRS pain scores at 0, 4, 8 and 24 hours postoperatively at rest, and cumulative NRS score at 24 hours at rest, to assess the time of first rescue analgesia and to compare total amount of rescue analgesia consumption in each group.  18 months 
To assess the incidence of Hemidiaphragmatic Paresis using USG guided diaphragmatic excursion and Pulmonary Function Test (FVC, FEV1 and PFR) using CONTEC Spirometer CMS - SP10 Spirometer at baseline and 30 minutes post block and 1 hour in PACU  18 months 
To assess the block characteristics like time of performance time of block, onset of sensory and motor block  18 months 
To assess total intra opertive Fentanyl consumption and Hemodynamic parameters like HR, MAP, SpO2  18 months 
 
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)   08/09/2025 
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="1"
Months="6"
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 prospective, randomized controlled study compares the effectiveness of Costoclavicular Block (CCB) and Superior Trunk Block (STB) for postoperative 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 (NRS) pain scores. Secondary objectives include assessing block characteristics such as onset and duration, measuring total opioid use in the first 24 hours after surgery, monitoring hemodynamic parameters and complications, evaluating ease of block performance and patient satisfaction.


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

 
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