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CTRI Number  CTRI/2022/04/041580 [Registered on: 01/04/2022] Trial Registered Prospectively
Last Modified On: 01/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare two approaches of interscalene brachial plexus block in arthroscopic shoulder surgery patients 
Scientific Title of Study   To compare the efficacy of two different approaches of Interscalene Brachial Plexus Block in patients undergoing arthroscopic shoulder surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Surabhi Sandill 
Designation  Senior Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  B-085 DLF Capital Greens, Shivaji Marg, Najafgarh Road, New Delhi

New Delhi
DELHI
110015
India 
Phone  9910180403  
Fax    
Email  surabhisandill@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Udismita Baruah 
Designation  Associate Professor 
Affiliation  VMMC and SJH 
Address  Main OT Building Anaesthesia Department Safdarjung Hospital New Delhi

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  udismitabaruah@gmail.com  
 
Details of Contact Person
Public Query  
Name  Udismita Baruah 
Designation  Associate Professor 
Affiliation  VMMC and SJH 
Address  Main OT Building Anaesthesia Department Safdarjung Hospital New Delhi

North East
DELHI
110029
India 
Phone    
Fax    
Email  udismitabaruah@gmail.com  
 
Source of Monetary or Material Support  
Safdarjung Hospital 
 
Primary Sponsor  
Name  Safdarjung Hospital 
Address  Main OT Building Anaesthesia Department Safdarjung Hospital New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 Surabhi Sandill  Safdarjung Hospital  Anaesthesia Department Main OT Building Ground Floor Safdarjung Hospital New Delhi NEW DELHI
New Delhi
DELHI 		 9910180403

surabhisandill@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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, (2) ICD-10 Condition: M244||Recurrent dislocation of joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CLASSICAL APPROACH INTERSCALENE BRACHIAL PLEXUS BLOCK  Under USG and PNS guidance, 10mL of 0.5% bupivacaine was injected during classical approach of interscalene brachial plexus block. 
Intervention  LOW APPROACH INTERSCALENE BRACHIAL PLEXUS BLOCK  Under USG and PNS guidance, 10mL of 0.5% bupivacaine was injected during low approach of interscalene brachial plexus block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult patients (18-65 years) of either sex
2. American Society of Anaesthesiology Physical Status ( ASA) Grade I/II with BMI b/w 20-35 kg/m2
3. Patients scheduled to undergo unilateral arthroscopic shoulder surgery
4. Patients can understand and comply with the study instructions
 
 
ExclusionCriteria 
Details  1. Patients with preexisting obstructive / restrictive lung diseases or preexisting hemi diaphragmatic dysfunction.
2. BMI > 35 kg/metre2
3. History of known local anesthetic allergy
4. History of neurological deficit in upper limbs
5. History of coagulopathy
6. Local site Infection
7. Pregnancy
8. Hepatic/ renal failure
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study and compare analgesia following interscalene brachial plexus block (classic Vs low)  Baseline, intra-operatively, post block upto 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To study and compare incidence of block characteristics (sensory-motor blockade, radiological spread, number of needle passes), respiratory functions, patient satisfaction and complications, if any.   Peri-operative monitoring of the block characteristics (sensory-motor blockade, radiological spread, number of needle passes), respiratory functions, patient satisfaction and complications  
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   09/04/2022 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

We undertake this study to compare the both techniques of intercalene brachial plexus block - classical approach (in the inter scalene groove at the level of C6) with the low approach (block at the site about 2/3rd of the distance caudally from C6) with aid of both USG and PNS to evaluate the analgesic efficacy, safety, sensory and motor block as well as to find out the proximal drug spread (to cervical plexus with aid of sensory dermatomal testing) & distal drug spread (to supraclavicular region with aid of regional fluoroscopy).

 

In this study, we will also compare the block characteristic like performance time, onset time, complications, sensory, motor block, procedural pain, operator experience, no. of time needle passes, analgesic efficacy, pain score, complication, assessment of motor strength & patient’s satisfaction.

 
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