| CTRI Number |
CTRI/2021/07/035010 [Registered on: 20/07/2021] Trial Registered Prospectively |
| Last Modified On: |
06/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare effects of Dexmedetomidine and Fentanyl added to Ropivacaine in brachial plexus block |
|
Scientific Title of Study
|
A comparative study of Dexmedetomidine and Fentanyl as adjuvants to Ropivacaine on analgesic efficacy in supraclavicular brachial plexus block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Malin Debnath |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur,795004, India
Imphal West
MANIPUR
795004
India |
| Phone |
9402319270 |
| Fax |
|
| Email |
dr.malindebnath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupendra Singh Thokchom |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West
Imphal West
MANIPUR
795004
India |
| Phone |
9774247043 |
| Fax |
|
| Email |
penbeeru63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupendra Singh Thokchom |
| Designation |
Associate Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West
Imphal West
MANIPUR
795004
India |
| Phone |
9774247043 |
| Fax |
|
| Email |
penbeeru63@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Imphal, Manipur |
|
|
Primary Sponsor
|
| Name |
Dr Malin Debnath |
| Address |
Post graduate trainee, Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur, 795004 |
| 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 Malin Debnath |
Regional Institute of Medical Sciences |
Department of Anaesthesiology, pre operative checkup room
Imphal West
MANIPUR |
9402319270
dr.malindebnath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS |
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 |
Ropivacaine with Dexmedetomidine |
30 ml 0.5% Ropivacaine with 1 microgram/kg Dexmedetomidine for supraclavicular brachial plexus block |
| Comparator Agent |
Ropivacaine with Fentanyl |
30 ml 0.5% Ropivacaine with 1 microgram/kg Fentanyl for supraclavicular brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I AND II |
|
| ExclusionCriteria |
| Details |
1. Uncooperative patients/ patients refusal
2. Patients having hypertension/ diabetes mellitus/ neuropathy/ Peripheral nerve injury
3. Geriatric/ pediatric patients
4. Pregnancy and lactation
5. Patients on anticoagulants or bleeding disorders
6. Hypersensitivity to Amide group of local anesthetic agents |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of sensory and motor block |
Every 2 minutes from injecting of drugs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/08/2021 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised trial, to compare analgesic efficacy of Dexmedetomidine ( 1 microgram/kg) and Fentanyl ( 1 microgram/kg) as adjuvants to Ropivacaine ( 30 ml 0.5%) in supraclavicular brachial plexus block, which will be conducted in the Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur, in 60 patients within the age group of 18-60 years and ASA grade I and II. Onset and duration of sensory and motor block will be recorded using Hollmen scale. |