| 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
|
|
|
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
|
|
|
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 burden. Interscalene 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 injections. Periarticular 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. |