| CTRI Number |
CTRI/2024/02/062480 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of analgesic effects of dexmedetomidine and ketamine in adductor canal block ( for post operative pain relief following unilateral TKR ) |
|
Scientific Title of Study
|
Evaluation of analgesic effects of ketamine versus dexmedetomidine as an adjuvant to 0.2% ropivacaine infusion in adductor canal block for post-operative analgesia following unilateral total knee replacement surgery. |
| 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 Gokuldas Sekhara Menon |
| Designation |
Associate Professor |
| Affiliation |
Amrita institute of medical science and research centre |
| Address |
First Floor , Tower 6 ,Department of Anesthesiology and critical care , Amrita institute of medical science and research centre ,
Ponekkara , Edapally , Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9847448005 |
| Fax |
|
| Email |
gokuldas75@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gokuldas Sekhara Menon |
| Designation |
Associate Professor |
| Affiliation |
Amrita institute of medical science and research centre |
| Address |
First floor , Tower 6 , Department of Anesthesiology and critical care , Amrita institute of medical science and research centre ,
Ponekkara , Edapally , Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9847448005 |
| Fax |
|
| Email |
gokuldas75@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahla Shamsudheen |
| Designation |
Junior Resident |
| Affiliation |
Amrita institute of medical science and research centre |
| Address |
First floor , Tower 6 , Department of Anesthesiology and critical , Amrita institute of medical science and research centre ,
Ponekkara , Edapally , Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8861643066 |
| Fax |
|
| Email |
nainashams@gmail.com |
|
|
Source of Monetary or Material Support
|
| First Floor , Tower 6 , Department of Anesthesiology and critical care , Amrita institute of medical science and research center , Ponekkara , Edapally , Kochi , Kerala |
|
|
Primary Sponsor
|
| Name |
Dr Sahla Shamsudheen |
| Address |
First Floor , Tower 6 , Department of Anesthesiology and critical care , Amrita institute of medical science and research center , Ponekkara , Edapally , Kochi , Kerala |
| 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 Sahla Shamsudheen |
Amrita institute of medical science and research centre |
Department of Anesthesiology and critical care , Amrita institute of medical science and research center , Ponekkara, AIMS P.O, Kochi, Kerala, India - 682 041.
Ernakulam
KERALA |
8861643066
nainashams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita institute of medical sciences and research centre ethical committee |
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 |
1) Ketamine
2) Dexmedetomidine |
1) Group A will receive an infusion of 0.2% Ropivacaine + Ketamine 1mg/kg at 8-10 ml/hr.(48ml 0.2% ropivacaine + 1mg/kg Ketamine diluted to 2ml – total 50ml)
2)Group B will receive an infusion of 0.2% Ropivacaine + Dexmedetomidine 1mcg/kg at 8-10 ml/hr. (48ml 0.2% ropivacaine + 1mcg/kg dexmedetomidine diluted to 2ml – total 50ml)
|
| Intervention |
Adductor canal block |
All patient undergoing unilateral knee replacement will receive 0.2% ropivacaine as an infusion in adductor canal block for post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologist physical status I-III |
|
| ExclusionCriteria |
| Details |
1) Allergy to local anaesthetics
2) Patient with history of previous knee surgeries
3) Patients with contra indications to spinal anaesthesia
4) Patients with history of chronic analgesic use |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients requiring additional opioids following ketamine versus dexmedetomidine as an adjuvant to ropivacaine infusion in adductor canal block |
24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 )Hemodynamic changes
2 ) To assess motor blockade
3 )Pain on ambulation.
4 )To compare adverse effects like hallucination , nausea , vomiting
|
4th hourly for 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
15/02/2024 |
| 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="0"
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
|
TKR is associated with associated with severe pain during post operative period . Therefor post operative pain management is of utmost importance for patient outcome and satisfaction . The current practice is to manage post operative pain with adductor canal block using local anaesthetic agents which provide good analgesia while preserving motor function . Various adjuvants have been used to prolong the duration of action of nerve blocks . In this study we plan to compare adjuvant effects of ketamine ( 1mg/kg ) and dexmedetomidine ( 1mcg/kg ) . Through a comparative analysis , this study aims to determine the optimal adjuvant for enhancing post operative pain management while minimizing adverse effects . |