| CTRI Number |
CTRI/2024/11/076919 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effects of ropivacaine alone versus ropivacaine combined with clonidine for pain relief in the nerve block used for arm surgery |
|
Scientific Title of Study
|
A comparative study of isobaric ropivacaine with clonidine and isobaric ropivacaine alone in supraclavicular brachial plexus block |
| 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 Nameirakpam Priyadarshini Devi |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of anaesthesia Varun arjun medical college and rohilkhand hospital lucknow road banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7005177035 |
| Fax |
|
| Email |
nameirakpam17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Tiwari |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7839310269 |
| Fax |
|
| Email |
rajeev.5mch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Chaurasia |
| Designation |
Assistant Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9354134385 |
| Fax |
|
| Email |
drgarima0011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital Lucknow road Banthara district Shahjahanpur Uttar Pradesh India pin code 242307 |
|
|
Primary Sponsor
|
| Name |
Dr Nameirakpam Priyadarshini Devi |
| Address |
room no 1004 department of anaesthesia first floor Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
District Shahjahanpur Uttar Pradesh |
| Type of Sponsor |
Other [self] |
|
|
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 Nameirakpam Priyadarshini Devi |
Rohilkhand Hospital |
Room no 1004 Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH |
7005177035
nameirakpam17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Varun Arjun Medical College & Rohilkhand Hospital NH24 Banthara shahjahanpur Uttar Pradesh 242307 India |
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 |
| Comparator Agent |
isobaric ropivacaine |
Patient scheduled for elective upper limb surgeries under supraclavicular brachial plexus block with 3mg per kg body weight of 0.75% isobaric ropivacaine diluted with normal saline to make a total volume of 30ml in one year |
| Intervention |
isobaric ropivacaine with clonidine |
Patient scheduled for elective upper limb surgeries under supraclavicular brachial plexus block with 3mg per kg body weight of 0.75% isobaric ropivacaine with 1mcg per kg of clonidine diluted with normal saline to make a total volume of 30ml in one year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I II
scheduled for elective upper limb orthopaedic surgeries under supraclavicular brachial plexus block
|
|
| ExclusionCriteria |
| Details |
Lack of patients consent
any other comorbidities COPD IHD HTN DM Renal or hepatic dysfunction etc
patients with a known contraindication to any of the study drugs
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the dose response relationship between isobaric ropivacaine with clonidine and isobaric ropivacaine alone regarding anaesthesia quality and duration |
every 5 minutes for 30 minutes every 30 minutes during the surgery and every hourly for 12 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate whether the addition of clonidine improves pain management reduce the need for opioids and prolongs the duration of analgesia |
every 5 minutes for 30 minutes every 30 minutes during the surgery and every hourly for 12 hours
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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
|
The study explores the efficacy of isobaric ropivacaine alone versus isobaric ropivacaine combined with clonidine in supraclavicular brachial plexus blocks for upper extremity surgeries brachial plexus blocks offer advantages over general anesthesia including reduced risks better pain relief and fewer complications like nausea and vomiting ropivacaine a local anesthetic works by blocking sodium channels to inhibit nerve impulse conduction selectively targeting pain transmitting fibers with less motor block clonidine when added to ropivacaine enhances the nerve block by modulating adrenergic pathways leading to prolonged sensory blockade and reduced postoperative pain the study aims to compare these two approaches to determine which provides better motor blockade longer duration of anesthesia, and improved postoperative pain management |