FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/02/031042 [Registered on: 05/02/2021] Trial Registered Prospectively
Last Modified On: 02/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of two types of nerve block-suprascapular nerve and axillary nerve, for pain relief in shoulder surgery. 
Scientific Title of Study   Comparision of perioperative analgesic effect of suprascapular nerve block and combined suprascapular and axillary nerve block in patients Undergoing 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  DrSubrata Ray 
Designation  Associate Professor 
Affiliation  KPC Medical College 
Address  Deptt. of Anaesthesiology KPC Medical College 1F Raja S C Mullick Road Jadavpur

South Twentyfour Parganas
WEST BENGAL
700032
India 
Phone  9830021157  
Fax    
Email  raysubrata62@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subrata Ray 
Designation  Associate Professor 
Affiliation  KPC Medical College 
Address  Deptt. of Anaesthesiology KPC Medical College 1F Raja S C Mullick Road Jadavpur

South Twentyfour Parganas
WEST BENGAL
700032
India 
Phone  9830021157  
Fax    
Email  raysubrata62@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SUBRATA RAY 
Designation  ASSOCIATE PROFESSOR 
Affiliation  KPC Medical College 
Address  Deptt. of Anaesthesiology KPC Medical College 1F Raja S C Mullick Road Jadavpur

South Twentyfour Parganas
WEST BENGAL
700032
India 
Phone  9830021157  
Fax    
Email  raysubrata62@gmail.com  
 
Source of Monetary or Material Support  
KPC Medical College , Jadavpur, Kolkata 
 
Primary Sponsor  
Name  Dr Subrata Ray 
Address  Deptt of Anaesthesiology KPC Medical College Jadavpur,Kolkata 700032 
Type of Sponsor  Other [INDIVIDUAL] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Anuradha Mitra  Deptt of Anaesthesiology KPC Medical College Jadavpur, Kolkata 700032 
Dr Ramapati Sanyal  Deptt of Anaesthesiology KPC Medical College Jadavpur,Kolkata 700032 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Subrata Ray  KPC Medical College  Deptt. of Anaesthesiology KPC Medical College 1F Raja S C Mullick Road Jadavpur
South Twentyfour Parganas
WEST BENGAL 		 9830021157

raysubrata62@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M659||Synovitis and tenosynovitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  axillary nerve block  Axillary nerve block will be done in posterior approach using nerve stimulator. Local anaesthetic lignocaine 2% and bupivacaine 0.25% will be used. 
Intervention  Suprascapular nerve block  Suprascapular nerve block will be done by landmark method with local anaesthetic agents. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA 1,2 AND 3.
WEIGHT 48 KGS TO 80 KGS. 
 
ExclusionCriteria 
Details  Anatomical anomaly around shoulder joint
ASA 4
Emergency surgery.
Coagulation disorder.
History of local anaesthetic toxicity
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS Score  post operative 
 
Secondary Outcome  
Outcome  TimePoints 
ANALGESIC REQUIREMENT.  INTRA-OPERATIVE AND POST-OPERATIVE PERIOD. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/02/2021 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
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-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  send request to E-mail:raysubrata62@gmail.com

  6. For how long will this data be available start date provided 01-08-2021 and end date provided 31-07-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Post-operative pain relief in shoulder surgery is of prime importance to early rehabilitation. Interscalene block is one of the methods used for the above purpose but has important complications. Suprascapular nerve block and axillary nerve block are can give comparable postoperative pain relief with less complications.
the aim of the present study is to compare the efficacy of the above nerve blocks using VAS score as the principal parameter.
 
Close