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CTRI Number  CTRI/2024/08/072691 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 19/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Controlling pain after arthroscopic surgeries - how does regional anaesthesia fair against simple injections around shoulder 
Scientific Title of Study   Analysing the efficacy of periarticular shoulder injections in pain control after arthroscopic rotator cuff repair 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Girinivasan Chellamuthu 
Designation  Junior Consultant 
Affiliation  MIOT International Hospital 
Address  Shoulder, elbow and wrist OPD, Main Block, MIOT International Hospital, 4/112, Mount Poonamallee Rd, Sathya Nagar, Manapakkam, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600089
India 
Phone  8667087047  
Fax    
Email  giri.c.nivasan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Girinivasan Chellamuthu 
Designation  Junior Consultant 
Affiliation  MIOT International Hospital 
Address  Shoulder, Elbow and Wrist OPD, Main block, MIOT International, 4/112, Mount Poonamallee Rd, Sathya Nagar, Manapakkam, Chennai, Tamil Nadu 600089

Chennai
TAMIL NADU
600089
India 
Phone  8667087047  
Fax    
Email  giri.c.nivasan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Girinivasan Chellamuthu 
Designation  Junior Consultant 
Affiliation  MIOT International Hospital 
Address  Shoudler, Elbow and Wrist OPD, Main Block, MIOT International Hospital, 4/112, Mount Poonamallee Rd, Sathya Nagar, Manapakkam, Chennai, Tamil Nadu 600089

Chennai
TAMIL NADU
600089
India 
Phone  8667087047  
Fax    
Email  giri.c.nivasan@gmail.com  
 
Source of Monetary or Material Support  
MIOT International Hospital, 4/112, Mount Poonamallee Rd, Sathya Nagar, Manapakkam, Chennai, Tamil Nadu 600089, India 
 
Primary Sponsor  
Name  MIOT International Hosptial 
Address  4/112, Mount Poonamallee Rd, Sathya Nagar, Manapakkam, Chennai, Tamil Nadu 600089 
Type of Sponsor  Private hospital/clinic 
 
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 Senthilvelan  MIOT International Hospital  Shoulder, Elbow and Wrist OPD, Department of Shoulder and Upper Limb Surgery, Main Block, 4/112, Mount Poonamallee Rd, Sathya Nagar, Manapakkam, Chennai, Tamil Nadu 600089
Chennai
TAMIL NADU 
8667087047

velansenthil78@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MIOT International Hospitals Institutional Ethics Committee  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Interscalene block  Comparison is with the interscalene block given by ultrasound guidance by the regional anaesthesia-trained anaesthesiologist; Drug used: Bupivacaine Dose: 0.5% Bupivacaine - 30 Ml Frequency: Only once 
Intervention  Periarticular shoulder injection  Periarticular shoulder injection involves the injection of a combination of drugs around the shoulder joint. Sites of Injection: 1. Portal sites 2. Suprascapular nerve 3. Axillary nerve 4. Subacromial bursa. With the arm at zero degrees abduction/neutral position and the patient in the lateral position, Suprascapular nerve landmark: A line is drawn along the scapular spine. A vertical line is drawn up from the inferior pole of the scapula to the scapular spine line. The suprascapular nerve is 2 cm lateral to the intersection point of these lines. Axillary nerve landmark: The posterolateral acromion and the axillary fold are connected through a line. The axillary nerve lies on the midpoint of this line Drugs used: Ropivacaine 200 mg Morphine 5 mg Adrenaline 0.3 mg Ketorolac 50 mg Route: Direct peri-articular injection frequency and duration: Only once before the start of the procedure.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients with rotator cuff tear planned for arthroscopic cuff repair 
 
ExclusionCriteria 
Details  Renal or liver compromise
Asthmatic patients
Glaucoma patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS pain score

 
3,12,24 and 48 hours post-surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
Analgesic requirement post-surgery  48 hours post surgery 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 4 
Date of First Enrollment (India)   01/09/2024 
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="1"
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 - NO
Brief Summary  

Shoulder surgeries are one of the common orthopaedic procedures performed. With the increasing activity level of the younger population and overall survivorship, the requirement of various shoulder surgeries like the arthroscopic Bankart repair, Latarjet procedure, rotator cuff repair and reverse shoulder arthroplasty are on the rise. These surgeries, particularly arthroscopic rotator cuff procedures, are known to cause increased post-operative pain and discomfort to the patients. This affects the post-op physiotherapy, demoralises the patient, and increases the overall analgesic requirement. Pain-sensitive patients may require increased hospital stay increasing economic burdenInterscalene Brachial Plexus Block (ISB) has been a standard procedure to reduce pain following shoulder surgeries. But this procedure is not without complications. There is a good amount of learning curve associated with it. The administration of ISB requires sophisticated equipment like a sonogram. Phrenic nerve palsy, pneumothorax, persistent neurological symptoms and rebound pain are known complications of interscalene block. The alternatives include the suprascapular nerve block, superior trunk block, and intra-articular and periarticular injectionsPeriarticular Injections are emerging as effective alternatives to IBPB with similar efficacy as shown by some recent studies. The main objective of this study is to analyse the clinical effectiveness of periarticular injections in controlling post-operative pain following arthroscopic rotator cuff repair surgeries compared to interscalene block.

 
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