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CTRI Number  CTRI/2025/08/093567 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study on different volumes of ropivacaine for arthroscopic shoulder surgery  
Scientific Title of Study   Comparison of incidence of hemidiaphragmatic paresis in conventional volume with low volume Superior Trunk block in patients undergoing arthroscopic shoulder surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sankarshan M 
Designation  PG Resident Doctor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar west, New Delhi - 110029 
Address  Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar west, New Delhi

New Delhi
DELHI
110029
India 
Phone  9538013495  
Fax    
Email  sankarshankoushik@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arushi Gupta 
Designation  Professor  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar west, New Delhi

New Delhi
DELHI
110029
India 
Phone  8800660246  
Fax    
Email  drarushigupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arushi Gupta 
Designation  Professor  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar west, New Delhi

New Delhi
DELHI
110029
India 
Phone  8800660246  
Fax    
Email  drarushigupta@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India 110029 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Ansari Nagar west, New Delhi-110029  
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 Sankarshan M   3rd floor OT complex , Sports Injury Centre   Department of Anaesthesia and Critical Care, OT complex, Sports Injury centre
New Delhi
DELHI 		 9538013495

sankarshankoushik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, Vardhman Mahavir college and Safdarjung Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound guided Superior Trunk block with 10ml of 0.5 % Ropivacaine   Drug - 10ml of 0.5% Ropivacaine Route - Ultrasound guided through block needle around nerve Frequency- once Duration - 30 mins Goal - Incidence of hemidiaphragmatic paresis in Ultrasound guided Superior Trunk block with 10ml of 0.5 % Ropivacaine 
Intervention  Ultrasound guided Superior Trunk block with 4ml of 0.5 % Ropivacaine   Drug - 4ml of 0.5% Ropivacaine Route - Ultrasound guided through block needle around nerve Frequency- once Duration - 30 mins Goal - Incidence of hemidiaphragmatic paresis in Ultrasound guided Superior Trunk block with 4ml of 0.5 % Ropivacaine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients (18-65 years) of American Society of Anesthesiologists (ASA)
physical status I or II scheduled to undergo arthroscopic shoulder surgery. 
 
ExclusionCriteria 
Details  1. Patients with known case of coagulopathies or on anticoagulant therapy. 2. Infection at the proposed site of the block. 3. Known allergies to effect of local anesthetics. 4. Preexisting Neurological deficit in upper limbs. 5. Preexisting lung diseases or hemidiaphragmatic dysfunction. 6. Arthroscopic Rotator cuff repair. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of hemidiaphragmatic paresis after conventional
volume with low volume Superior Trunk block in patients undergoing
arthroscopic shoulder surgery as determined by diaphragmatic excursion
using ultrasound. 		 Pre op, 30 mins post block ,1hr Post Op 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the PFTs ( Pulmonary Function Tests) after conventional
volume with low volume Superior Trunk block in patients undergoing
arthroscopic shoulder surgery. 2. To compare the efficacy of postoperative analgesia provided by the
different volumes of ropivacaine used in superior trunk block by NRS score. 3. To assess the duration of analgesia , intra op fentanyl consumption and
total postoperative opioid consumption within the first 24 hours among the
three groups. 		 NRS pain scoring at 1hr,2hr,4hr & 24hr postoperative  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 
Date of First Enrollment (India)   01/10/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sankarshankoushik@gmail.com].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 01-09-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This prospective randomized study compares the incidence of hemidiaphragmatic paresis and analgesic efficacy between low volume 4 mL and conventional volume 10 mL of 0.5 percent ropivacaine in ultrasound guided superior trunk block for arthroscopic shoulder surgery. Arthroscopic Bankart repair is associated with significant postoperative pain, and while interscalene brachial plexus block is effective, it frequently causes ipsilateral hemidiaphragmatic paresis, limiting use in patients with respiratory compromise. Superior trunk block targets C5 and C6 nerve roots to provide effective analgesia with potentially less phrenic nerve involvement, but the optimal local anesthetic volume is unclear. Seventy ASA I to II patients aged 18 to 65 years will be allocated to two groups receiving either 4 mL or 10 mL ropivacaine. Primary outcome is the incidence of hemidiaphragmatic paresis assessed by ultrasound diaphragmatic excursion. Secondary outcomes include pulmonary function tests, numeric rating scale pain scores, intraoperative fentanyl use, time to first rescue analgesia, postoperative tramadol use, and patient satisfaction. The study aims to determine the smallest effective volume that provides adequate analgesia while preserving respiratory function. 
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