| CTRI Number |
CTRI/2025/04/084113 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Interscalene nerve block with ropivacaine 0.5% versus ropivacaine 0.5% and Dexmedetomidine |
|
Scientific Title of Study
|
A Prospective randomized and double blinded study comparing duration of post operative analgesia between ultrasound guided Interscalene block with Ropivacaine 0.5 percent and Interscalene block with Ropivacaine 0.5 percent and Dexmedetomidine as adjuvant for shoulder arthroscopic surgeries done under General anesthesia |
| 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 Aravindh Veeresh |
| Designation |
Post graduate - Anaesthesia |
| Affiliation |
SRM institute of medical sciences |
| Address |
Dr. Aravindh Veeresh,
Anaesthesia Post graduate,
Anaesthesia Department,
SRM institute of medical sciences,
Vadapalani,
Chennai.
No.1, Jawaharlal Nehru road, Vadapalani, chennai
Chennai
TAMIL NADU
600026
India |
| Phone |
7010897280 |
| Fax |
|
| Email |
aravindh10veeresh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aanand Shankar |
| Designation |
Senior consultant Anaesthesiologist |
| Affiliation |
SRM institute of medical sciences |
| Address |
Dr. Aanand Shankar,
Senior consultant,
Anaesthesia department,
SRM Institute of medical sciences,
Vadapalani,
Chennai.
No.1, Jawaharlal Nehru road, Vadapalani, chennai
Chennai
TAMIL NADU
600026
India |
| Phone |
9841440448 |
| Fax |
|
| Email |
draanandshankar80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aravindh Veeresh |
| Designation |
Post graduate - Anaesthesia |
| Affiliation |
SRM institute of medical sciences |
| Address |
Dr. Aravindh Veeresh,
Anaesthesia Post graduate,
Anaesthesia Department,
SRM institute of medical sciences,
Vadapalani,
Chennai.
No.1, Jawaharlal Nehru road, Vadapalani, chennai
Chennai
TAMIL NADU
600026
India |
| Phone |
7010897280 |
| Fax |
|
| Email |
aravindh10veeresh@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM institute of medical sciences,
No.1 , Jawaharlal Nehru road,
Vadapalani,
Chennai,
India.
Pincode: 600026 |
|
|
Primary Sponsor
|
| Name |
SRM institute of medical sciences |
| Address |
SIMS Hospital,
No.1, Jawaharlal Nehru road, Vadapalani,
Chennai,
India.
Pincode: 600026 |
| 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 Aravindh Veeresh |
SRM institute of medical sciences |
Operation theatre and Pre anaesthesia room,
Anaesthesia department
SIMS Hospital,
No.1, Jawaharlal Nehru road,
Vadapalani,
Chennai,
India.
Pincode: 600026
Chennai
TAMIL NADU |
7010897280
aravindh10veeresh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIMS institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interscalene block
|
USG guided Interscalene block with Ropivacaine 0.5 percent
Duration: 5 to 10 minutes
Observation: 48 hours post procedure |
| Comparator Agent |
Interscalene block |
USG guided interscalene block with ropivacaine and ropivacaine and dexmedetomidine
Duration: 5 to 10 minutes
Observation: 48 hours post procedure |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
Patients admitted for shoulder arthroscopic surgery |
|
| ExclusionCriteria |
| Details |
ASA grade 3 and 4
Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the postoperative analgesia in Group A and B
|
30 minutes, 2 hours, 6 hours, 18 hours, 24 hours, 36 hours, 48 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the motor weakness & rescue analgesic requirement |
30 minutes 2 hours 6 hours 18 hours 24 hours 36 hours 48 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/04/2025 |
| 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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - IN study publication
- For how long will this data be available start date provided 20-10-2026 and end date provided 20-10-2036?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
USG guided interscalene block for patients posted for shoulder arthroscopic surgery in SIMS hospital |