| CTRI Number |
CTRI/2023/05/052872 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison between Continuous Femoral nerve block and Continuous Adductor canal block for Post operative pain relief in one sided Total knee replacement (TKR) surgeries. |
|
Scientific Title of Study
|
A Prospective Comparative study between Continuous Femoral nerve block and Continuous Adductor canal block for Post operative analgesia in Unilateral Primary Total knee arthroplasty (TKA) surgeries . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Minoti Kamdar |
| Designation |
DNB student |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital |
| Address |
Department of Anaesthesia
Kokilaben Dhirubhai Ambani Hospital
Andheri west
Mumbai
Department of Anaesthesia
Kokilaben Dhirubhai Ambani Hospital
Andheri west
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
9702810568 |
| Fax |
|
| Email |
minotikamdar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTejasi Waigankar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital |
| Address |
Department of Anaesthesia
Kokilaben Dhirubhai Ambani Hospital
Andheri west
Mumbai
Department of Anaesthesia
Kokilaben Dhirubhai Ambani Hospital
Andheri west
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
9702810568 |
| Fax |
|
| Email |
tejasi_d80@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Minoti Kamdar |
| Designation |
DNB student |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital |
| Address |
Department of Anaesthesia
Kokilaben Dhirubhai Ambani Hospital
Andheri west
Mumbai
Department of Anaesthesia
Kokilaben Dhirubhai Ambani Hospital
Andheri west
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
9702810568 |
| Fax |
|
| Email |
minotikamdar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Kokilaben Dhirubhai Ambani Hospital
Andheri west
Mumbai 400053
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Kokilaben Dhirubhai Ambani Hospital |
| Address |
Department of Anaesthesia
Kokilaben Dhirubhai Ambani Hospital
Four Bungalows
Andheri west
Mumbai 400053 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Minoti Kamdar |
Kokilaben Dhirubhai Ambani Hospital |
Department of Anaesthesia
Kokilaben Dhirubhai Ambani Hospital
Andheri west
Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9702810568
minotikamdar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous Adductor nerve Block
|
Continuous Adductor nerve Block
15ml 0.2% Ropivacaine Single shot
0.1% Ropivacaine via elastomeric pump at 7ML/HR for 48hrs
|
| Intervention |
Continuous Femoral nerve Block
|
Continuous Femoral nerve Block
15ml 0.2% Ropivacaine Single shot
0.1% Ropivacaine via elastomeric pump at 7ML/HR for 48hrs
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age group: 18yrs and above
All patients who would voluntarily agree to sign informed consent form.
All patients undergoing U/L Primary Total Knee Arthroplasty
No contraindication to paracetamol, opioids and NSAIDS.
Spinal/General Anaesthesia
Physical status ASA I and II |
|
| ExclusionCriteria |
| Details |
Bilateral TKA at the same time
Revision TKA
Physical status ASA III and above |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the functional outcome of continuous femoral nerve
block, continuous versus Adductor canal block in TKA patients and design a
clinical analgesic pathway.
|
Pain score at rest at 12hrs
pain score at rest and post exercise at 24hrs and 48hrs
nausea and vomiting at 12hrs, 24hrs and 48hrs
total fentanyl PCA requirement at 48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total opiod requirement of IV Fentanyl PCA postoperatively in
48hrs in both groups of patients. |
48hrs |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
19/05/2023 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a prospective,comparative studySample After routine pre-operative investigations and history, written informed consent will be taken. The method of analgesia will be decided by a computer generated list. On the day of surgery, pain, nausea and vomiting will be assessed. The physiotherapist will assess the muscle strength, pain at rest and post physiotherapy at 24hrs and 48 hrs using our pre-designed case record forms. Muscle strength will be assessed using Manual muscle testing scale and pain using the VAS score Total opiod requirement in 48hrs will be recorded. |