| CTRI Number |
CTRI/2025/10/095991 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing new infraspinatus teres minor block with traditional interscalene block for pain relief after shoulder surgery |
|
Scientific Title of Study
|
Comparison of infraspinatus- teres minor interfascial block and interscalene block for post operative analgesia in patients undergoing 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 Saurabh Dahiya |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of anaesthesia and intensive care vardhman mahavir medical college and safdarjung hospital, Ansari nagar, 110029 New delhi
South
DELHI
110029
India |
| Phone |
8750969184 |
| Fax |
|
| Email |
sourabh.dahiya2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Guria |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of anaesthesia and intensive care vardhman mahavir medical college and safdarjung hospital, Ansari nagar, 110029 New delhi
South
DELHI
110029
India |
| Phone |
8750969184 |
| Fax |
|
| Email |
sushilguria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Dahiya |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of anaesthesia and intensive care vardhman mahavir medical college and safdarjung hospital, Ansari nagar, 110029 New delhi
South
DELHI
110029
India |
| Phone |
8750969184 |
| Fax |
|
| Email |
sourabh.dahiya2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari nagar,110029 New delhi |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari nagar east,New Delhi,110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Saurabh Dahiya |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of anaesthesia and intensive care vardhman mahavir medical college and safdarjung hospital.
South
DELHI |
8750969184
sourabh.dahiya2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M244||Recurrent dislocation of joint, (2) ICD-10 Condition: M242||Disorder of ligament, (3) ICD-10 Condition: M243||Pathological dislocation of joint,not elsewhere classified, (4) ICD-10 Condition: M751||Rotator cuff tear or rupture, notspecified as traumatic, (5) ICD-10 Condition: M755||Bursitis of shoulder, (6) ICD-10 Condition: M753||Calcific tendinitis of shoulder, (7) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infraspinatus- teres minor interfascial block |
ultrasound guided Infraspinatus- teres minor interfascial block with 20ml of 0.375% Ropivacaine + 4mg Dexamethasone |
| Intervention |
Interscalene Block |
ultrasound guided interscalene brachial plexus block with 10ml of 0.375% Ropivacaine + 4mg Dexamethasone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2 |
|
| ExclusionCriteria |
| Details |
Patients with known case of coagulopathies or on anticoagulant therapy/infection at the proposed site of block/ known allergies to effect of local anesthetics / Preexisting Neurological deficit in upper limbs / Preexisting lung diseases or hemidiaphragmatic dysfunction. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NRS Score postoperatively. |
NRS Score postoperatively at 30 minutes, 2,4,6,12,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diaphragmatic excursion (in %) at preblock, 30mins post block. |
30 minutes post block |
| Total intraoperatively fentanyl requirement |
During block |
| Total tramadol requirement |
24 hours postoperative period |
| QoR-15 |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/10/2025 |
| 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
|
To compare Infraspinatus- teres minor interfascial block and Interscalene block for post operative analgesia in patients undergoing arthroscopic shoulder surgery using Numeric Rating Scale (NRS) Pain Score at 6 hours. SECONDARY OBJECTIVE |