| CTRI Number |
CTRI/2023/12/060675 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
We we want to see if dexmedetomidine make’s ropivacaine better for pain. We inject ropivacaine near knee nerve with a camera and needle. We compare pain after a knee surgery with or without dexmedetomidine. |
|
Scientific Title of Study
|
Evaluation of analgesic efficacy of dexmedetomidine as adjuvant with ropivacaine in usg guided adductor canal block in patients undergoing knee arthroscopic 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 |
Simran Kaur Virk |
| Designation |
Post Graduate Resident |
| Affiliation |
Indraprastha University |
| Address |
Department of Anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8146811709 |
| Fax |
|
| Email |
simmivirk96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Dr Dharam Singh Meena |
| Address |
Department of Anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, New Delhi |
| Type of Sponsor |
Other [VMMC and SJH] |
|
|
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 Simran Kaur Virk |
Safdarjung Hospital |
Sports Injury Complex, Second floor O.T,Vardhman Mahavir medical college and Safdarjung hospital, New Delhi
New Delhi
DELHI |
8146811709
simmivirk96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M20-M25||Other joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ropivacaine |
Patients undergoing knee arthroscopic surgeries will be given post op usg guided adductor canal block with ropivacaine only and will be checked for pain 24 hrs post op |
| Intervention |
Ropivacaine plus dexmedetomidine |
Patients undergoing knee arthroscopic surgeries will be given post op usg guided adductor canal block with dexmedetomidine plus ropivacaine for pain 24 hrs post op |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of anaesthesiologists physical status grade I and II scheduled for laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Allergy to amide group of local anaesthetic agent,
Significant neurological disease in lower limb, renal disease or psychiatric history,
Patient on anticoagulants or known case of bleeding disorder |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the quality of post-operative analgesia with respect to the intensity (using Visual Analogue Scale) in patients given ropivacaine with dexmedetomidine versus ropivacaine |
24 hours after block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the total requirement of rescue analgesic in both the groups |
24 hours after block |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/01/2024 |
| 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="6"
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
|
The study is undertaken to evaluate analgesic efficacy of dexmedetomidine as adjuvant to ropivacaine in patients undergoing knee arthroscopic surgeries.Primarily we will be checking VAS score in first 24hr and secondarily we will be seeing requirements of rescue analgesic. |