| CTRI Number |
CTRI/2024/07/071723 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different methods of brachial plexus blocks viz superior trunk block and interscalene block for providing pain relief after endoscopic shoulder surgery. |
|
Scientific Title of Study
|
Interscalene Block vs Superior Trunk Block for Post Operative Analgesia After Arthroscopic Shoulder Surgery- A Randomized Comparative Study |
| 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 Simran Chandwani |
| Designation |
DNB |
| Affiliation |
BLK Max Superspeciality Hospital |
| Address |
Department of Anesthesia, BLK Max Superspeciality Hospital, Pusa Road, New Delhi
Central
DELHI
110005
India |
| Phone |
7989173367 |
| Fax |
|
| Email |
simranchandwani01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Garg |
| Designation |
Senior Consultant |
| Affiliation |
BLK Max Superspeciality Hospital |
| Address |
Department of Anesthesia, BLK Max Superspeciality Hospital, Pusa Road, New Delhi
Central
DELHI
110005
India |
| Phone |
9654770390 |
| Fax |
|
| Email |
drdineshgarg1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Garg |
| Designation |
Senior Consultant |
| Affiliation |
BLK Max Superspeciality Hospital |
| Address |
Department of Anesthesia, BLK Max Superspeciality Hospital, Pusa Road, New Delhi
Central
DELHI
110005
India |
| Phone |
9654770390 |
| Fax |
|
| Email |
drdineshgarg1@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLK Max Superspeciality Hospital, Puma Road, New Delhi-110005 |
|
|
Primary Sponsor
|
| Name |
BLK-MAx superspeciality Hospital |
| Address |
BLK-MAX superspeciality Hospital,
Pusa Road, New Delhi-110005 |
| 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 Dinesh Garg |
BLK Max Superspeciality Hospital |
Department of Anaesthesia, BLK Max Superspeciality Hospital, Pusa Road Delhi-110005
Central
DELHI |
9654770390
drdineshgarg1@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S460||Injury of muscle(s) and tendon(s)of the rotator cuff of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brachial plexus block |
Interscalene block for post operative analgesia after arthroscopic shoulder surgery |
| Comparator Agent |
Brachial plexus block |
Superior trunk block for [post operative analgesia after arthroscopic shoulder surgery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA GRADE I AND II
2. POSTED FOR ARTHROSCOPIC SHOULDER SURGERY |
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Patients unwilling to participate in the study.
3. Significant psychiatric or cognitive conditions interfering with consent OR or post operative pain assessment.
4. Pre-existing neurological deficits or neuropathy affecting brachial plexus.
5. Pre-existing chronic pain or opioid use.
6. Significant renal or hepatic impairment.
7. History suggestive of obstructive sleep apnea..
8. Contraindications to peripheral nerve block, including local skin infection, bleeding diathesis, local anesthetic allergy, prior surgery in the neck, etc.
9. Allergy to any component of multimodal analgesia. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain scores and patient satisfaction scores in the first 24 hrs.
2. Total opioid consumption in the first 24 hrs post operatively. |
Post operatively AT 1,2,4,6,12 AND 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Diaphragmatic involvement.
2. Adverse effects. |
Post operatively at 1,2,4,6,12 AND 24 hrs. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/08/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Patient recruitment will be done according to the inclusion and exclusion criteria as mentioned earlier. The post -operative analgesic efficacy of inter scalene and superior trunk block will be compared in this study with the help of pain scores , patient satisfaction scores and post operative use of opioids, while taking care of the adverse outcomes related to each block. |