| CTRI Number |
CTRI/2025/02/081174 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the analgesic effect and duration of ropivacaine with and without dexmedetomidine postoperativey in forearm surgeries |
|
Scientific Title of Study
|
Comparison of ropivacaine with and without dexmedetomidine in infraclavicular brachial plexus block for postoperative analgesia in forearm surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D Sanitha kumari |
| Designation |
Junior resident |
| Affiliation |
Dr. D.Y.Patil hospital and research center |
| Address |
Dr. D.Y.patil hospital and research centre, Bhosalewadi,Kolhapur
Kolhapur
MAHARASHTRA
416005
India |
| Phone |
8297685133 |
| Fax |
|
| Email |
sanithakushwaha.dsk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmee Vijay Chavan |
| Designation |
Professor |
| Affiliation |
Dr.D.Y.Patil hospital and research center |
| Address |
602, vastushree vrindavan shivaji park,Kolhapur
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9823243848 |
| Fax |
|
| Email |
rashmeechavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmee Vijay Chavan |
| Designation |
Professor |
| Affiliation |
Dr.D.Y.Patil hospital and research center |
| Address |
602, vastushree vrindavan shivaji park,Kolhapur
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9823243848 |
| Fax |
|
| Email |
rashmeechavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y.Patil hospital and research centre, Kadamwadi,Kolhapur
Maharashtra, India -416003 |
|
|
Primary Sponsor
|
| Name |
D Sanitha kumari |
| Address |
Department of anaesthesia,D.Y.patil medical college and hospital, kadamwadi,Kolhapur,Maharashtra, India-416003 |
| 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 Rashmee Vijay Chavan |
D.Y.Patil hospital and research center |
Department of anaesthesiology,
D.Y.Patil medical college and hospital,kolhapur
Kolhapur
MAHARASHTRA |
9823243848
rashmeechavan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, D.Y.Patil medical college,Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Forearm surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ropivacaine alone |
Group receives only ropivacaine without any additives,using infraclavicular brachial plexus block technique with similar volume and concentration of ropivacaine as the interventional group, ensuring comparibility and documenting rescue analgesia requirement for 24hours |
| Intervention |
Ropivacaine with dexmedetomidine |
The group receives combination of drug based on mg/kg body weight via infraclavicular brachial plexus block, targeting the nerves of forearm for postoperative analgesia which will be monitored for 24hour after surgery |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I&2 |
|
| ExclusionCriteria |
| Details |
Patient not giving consent
Local skin infections
Significant cardiac disease and patients on beta blockers.
Suspected coagulopathy or bleeding diathesis
Allergy to local anesthetics and study drug.
Psychiatric Illness
Chronic preoperative opioid consumption
Procedure posted for other than supine position |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Time for rescue analgesia |
Measured post-operatively at regular intervals 0,4,8,12,16,20,24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Visual analog scale (VAS) score
2. Ramsay sedation score |
Measured post-operatively at regular intervals 0,4,8,12,16,20,24hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2025 |
| 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 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
|
Summary:
This prospective, comparative study evaluates the efficacy of ropivacaine with and without dexmedetomidine for infraclavivular brachial plexus block in forearm surgeries, focusing on post-operative analgesia
Methodology:The patients are randomised into two groups (Group A and Group B) of 20 patients each using computer generated random number method. Group A patients will receive Plain 0.75% Ropivacaine and Group B patients will receive 0.75% Ropivacaine with 1μg/kg Dexmedetomidine
The following parameters will be recorded post-operatively at fixed time intervals: -vas score -Ramsay sedation score -time for rescue analgesia |