| CTRI Number |
CTRI/2024/11/076655 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The analgesic effect of ROPIVACAINE versus ROPIVACAINE with DEXAMETHASONE when given in ultrasound guided ADDUCTOR CANAL BLOCK will be compared in patients undergoing knee surgeries |
|
Scientific Title of Study
|
To assess the post-operative analgesic effect of single-shot ropivacaine versus ropivacaine with dexamethasone in adductor canal block for knee surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MMCH/IEC/24/871 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abha Agnihotri |
| Designation |
Junior Resident |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Solan |
| Address |
Department of Anesthesiology, Third floor, Maharishi
MARKANDESHWAR MEDICAL COLLEGE AND HOSPITAL
,KUMARHATTI
Solan
HIMACHAL PRADESH
173229
India
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8556047446 |
| Fax |
|
| Email |
abhaagnihotri99999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSmriti Anand |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital,Kumarhatt |
| Address |
Department of Anaesthesiology, Third floor, Maharishi
Markandeshwar Medical College and Hospital,Kumarhatti
Solan
HIMACHAL PRADESH
173229
India
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9418079103 |
| Fax |
|
| Email |
gupta.smriti1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abha Agnihotri |
| Designation |
Junior Resident |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Solan |
| Address |
Department of Anesthesiology, Third floor, Maharishi
MARKANDESHWAR MEDICAL COLLEGE AND HOSPITAL
,KUMARHATTI
Solan
HIMACHAL PRADESH
173229
India
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8556047446 |
| Fax |
|
| Email |
abhaagnihotri99999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital,Kumarhatti,solan, Himachal pradesh
india 173229 |
|
|
Primary Sponsor
|
| Name |
Dr Abha Agnihotri |
| Address |
Department of Anaesthesiology, Third floor, Maharishi
Markandeshwar Medical College and Hospital,Kumarhatti, Solan
HIMACHAL PRADESH
173229
India |
| 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 Abha Agnihotri |
Maharishi Markandeshwar Medical College And Hospital |
O.T. complex, Third
floor 301, Department
of Anaesthesia,
Maharishi
Markandeshwar
Medical College And
Hospital
Solan
HIMACHAL PRADESH
Solan
HIMACHAL PRADESH |
8556047446
abhaagnihotri99999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Medical College And Hospital, Kumarhatti, SolanHIMACHAL PRADESH 173229 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 |
ropivacaine with dexamethasone |
0.2% of Ropivacaine with (8mg)-2ml of dexamethasone - total drug volume of 32ml is given in adductor canal after knee surgery |
| Intervention |
Ropivacaine with normal saline |
0.2% of 30 ml of Ropivacaine +2ML of normal saline -total drug volume of 32 ml is given in Adductor canal After knee surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients above the age of 18, under ASA grade I and II, undergoing uneventful
knee surgeries and giving written informed consent to participate in the study will
be included. |
|
| ExclusionCriteria |
| Details |
1.Patients below the age of 18.
2.Pregnant women.
3.Rashes on the site of procedure.
4.Bleeding disorders.
5.Uncontrolled hypertension, bradycardia, on beta-blockers or history of any
cardiovascular diseases.
6.Psychiatric illness.
7.Patient on any chronic medication.
8.History of hypersensitivity to local anaesthetics.
9.All patients included in ASA grading III & IV. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the postoperative analgesic effect of Ropivacaine with normal saline and Ropivacaine with Dexamethasone after knee surgeries when given in ACB.Duration of analgesia that is duration between administration of block and first
rescue analgesic. |
0, 6, 12, 18, 24 and 48 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare requirement of post-surgery rescue analgesic after using visual acuity
score |
Total number of rescue analgesics administered in first 48 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/11/2024 |
| 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="2"
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
|
The selected patients will either receive 30 ml of 0.2% ropivacaine with 2 ml of normal saline or 30 ml of 0.2% ropivacaine with 2 ml (8 mg) dexamethasone after completion of knee surgeries under spinal anaesthesia. Pain will be assessed at different time intervals using VAS score and rescue analgesics will be given accordingly. |