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CTRI Number  CTRI/2024/01/061518 [Registered on: 16/01/2024] Trial Registered Prospectively
Last Modified On: 14/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Pain Relief Techniques After Arthroscopic Shoulder Surgery: A comparative study  
Scientific Title of Study   A Randomised Double Blind Study Comparing Post Operative Analgesic Efficacy of High Thoracic Erector Spinae Plane Block with Peri Articular Injection in 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  Dr Sneha Shashikumar 
Designation  Junior resident Anaesthesia 
Affiliation  bharati vidyapeeth deemed university medical college, pune 
Address  Departement of Anaesthesia Bharati hospitals Bharati vidyapeeth deemed university medical college Bharati Pune Satara Road Dhankawadi Katraj Pune Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  7025096228  
Fax    
Email  snehaanair.4.1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhay Sancheti 
Designation  Associate Professor 
Affiliation  bharati vidyapeeth deemed university medical college, pune 
Address  Departement of Anaesthesia Bharati hospitals Bharati vidyapeeth deemed university medical college Bharati Pune Satara Road Dhankawadi Katraj Pune Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9371107686  
Fax    
Email  abhi6264@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijayalaxmi Biradar 
Designation  Assistant Professor 
Affiliation  bharati vidyapeeth deemed university medical college, pune 
Address  Departement of Anaesthesia Bharati hospitals,Bharati vidyapeeth deemed university medical college Bharati Pune Satara Road Dhankawadi Katraj, Pune Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9638716764  
Fax    
Email  vijayalaxmibiradar@gmail.com  
 
Source of Monetary or Material Support  
Bharati hospital and Research Centre, Pune  
 
Primary Sponsor  
Name  Dr Sneha Shashikumar 
Address  Departement of Anaestheia, 3rd floor, MOT complex, Bharati hospitals, Bharati vidyapeeth deemed university medical college, Pune Satara Road, Dhankawadi, Katraj, Pune, Maharashtra - 411043 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Abhay Sancheti   Departement of Anaestheia, Bharati hospitals, Bharati vidyapeeth deemed university medical college, Pune Satara Road, Dhankawadi, Katraj, Pune, Maharashtra - 411043 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijayalaxmi Biradar  Bharati hopsital, Bharati deemed university medical college, pune  Bharati Hospital,Bharati vidyapeeth deemed university medical college, Pune-Satara Road, Dhankwadi, Pune - 411 043
Pune
MAHARASHTRA 		 9638716764

biradarvijaya06@gmail.com 
Dr Sneha Shashikumar  Bharati hospital and Research Center  Bharati deemed university medical college, room 104, staff quarters C-Wing, Pune Satara Road Dhankawadi Katraj Pune Maharashtra 411043
Pune
MAHARASHTRA 		 7025096228

snehaanair.4.1996@gmail.com 
Dr Abhay Sancheti   Bharati hospital and Research center, Pune  Departement of Anaesthesia Bharati vidyapeeth deemed university medical college, Pune-Satara Road, Dhankwadi, Pune - 411043
Pune
MAHARASHTRA 		 9371107686

abhi6264@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr Sneha Shashikumar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  errector spinae plane block  The Erector Spinae Plane Block is carried out by injecting local anaesthetic near the tip of the transverse process of the vertebra, deeper to the erector spinae muscle. duration: before extubation, takes 20-25 minutes 
Comparator Agent  peri articular injectiom   Peri-Articular injection analgesia is an innovative and a minimally invasive method The local anaesthetic is injected by the surgeon at the conclusion of the surgical process into the subacromial spaces intra articular spaces and between the port sites 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults above the age of 18 years
ASA I II and III patients
All elective Shoulder arthroscopic surgeries under General Anaesthesia of 2 to 4 hr duration
 
 
ExclusionCriteria 
Details  Patients Refusal to participate in the study
Presence of any peripheral sensorineural deficit of the limb to which block will be given
Known allergy to the local anaesthetic drugs
Contraindication to Erector spinae plane block or Peri articular injection
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Intensity of postoperative pain by Numerical Rating Score (NRS)   3 hours  
 
Secondary Outcome  
Outcome  TimePoints 
1)Duration of post-operative analgesia after each block
2)Total number of analgesic doses required in first 24 hours
3)Side effects if any like nausea vomiting, local anaesthetic systemic toxicity
 		 for 24 hours after giving block 
 
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   N/A 
Date of First Enrollment (India)   28/01/2024 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [snehaanair.4.1996@gmail.com].

  6. For how long will this data be available start date provided 08-11-2023 and end date provided 08-11-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
 Shoulder arthroscopic surgeries are minimally invasive surgeries to diagnose and treat shoulder pathologies. The ability to effectively control postoperative pain enables early mobilisation, efficient surgical rehabilitation and shorter hospital stays.
 Several nerve block techniques have been used for pain management following shoulder arthroscopic surgeries out of which Interscalene block is considered to be a standard technique. However there are several risks associated with this approach and considering  these risks, investigating other localised blocks that have the potential to provide effective pain analgesia with fewer side effects is crucial.
 As per our detailed literature research, there are very few studies comparing the effectiveness of Erector Spinae Plane Block and  Peri-Articular injection for postoperative analgesia.
  In this study, we aim to compare the Post operative analgesic efficacy of Erector Spinae Plane Block and Peri-Articular injection in shoulder arthroscopic surgeries.
 
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