| CTRI Number |
CTRI/2024/04/065671 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Patient undergoing total knee replacement surgery for postoperative analgesia comparing 0.125% Bupivacaine and 0.2% Ropivacaine infusion for adductor canal block |
|
Scientific Title of Study
|
Prospective randomized double-blind study to compare 0.125% Bupivacaine and 0.2% Ropivacaine infusion for adductor canal block after Total knee Arthroplasty for postoperative analgesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSakshi Khatri |
| Designation |
Postgraduate |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
A-Block Department of Anesthesia
D Y Patil School of Medicine
Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra
Thane MAHARASHTRA 400706 India |
| Phone |
9049666609 |
| Fax |
|
| Email |
sakshi07sep@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrMona Jadhav |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
A-Block Department of Anesthesia
D Y Patil School of Medicine
Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra
Thane MAHARASHTRA 400706 India |
| Phone |
9763847148 |
| Fax |
|
| Email |
monajadhav601@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrMona Jadhav |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
A-Block Department of Anesthesia
D Y Patil School of Medicine
Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra
MAHARASHTRA 400706 India |
| Phone |
9763847148 |
| Fax |
|
| Email |
monajadhav601@hotmail.com |
|
|
Source of Monetary or Material Support
|
| D. Y. Patil University School of Medicine and Hospital, Nerul, Navi Mumbai
Department of Anaesthesiology
|
|
|
Primary Sponsor
|
| Name |
D Y Patil University School of Medicine and Hospital Nerul Navi Mumbai |
| Address |
A-Block Department of Anesthesia
D Y Patil School of Medicine
Ayyappa Temple Rd Dr D Y Patil Vidyanagar Sector 5 Nerul Navi Mumbai Maharashtra |
| 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 |
| Dr Sakshi Khatri |
D. Y. Patil University School of Medicine and Hospital, Nerul, Navi Mumbai |
A block Department of Anesthesia
Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 Thane MAHARASHTRA |
9049666609
sakshi07sep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health research of Dr D Y Patil Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Infusion of 0.125% Bupivacaine in adductor canal block |
Dose - 0.125% Bupivacaine
Route of Administration - catheter in adductor canal
Duration - 2 days
Rate - 7ml/hour |
| Comparator Agent |
Infusion of 0.2% Ropivacaine via adductor canal block |
Dose - 0.2% Ropivacaine
Route of Administration - catheter in adductor canal
Duration - 2 days
Rate - 7ml/hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
89.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing TKR.
All the adult patients.
ASA grade I and II.
Patients giving consent for study.
|
|
| ExclusionCriteria |
| Details |
Patients with coagulopathy.
Allergy to local anaesthetics.
Infection at the site of block.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Analgesic efficacy (VAS score 1-10) ; 10 is the worst pain.
|
Analgesic efficacy (VAS score 1-10) ; 10 is the worst pain.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total consumption of rescue analgesia |
In 24 hour |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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 4 |
|
Date of First Enrollment (India)
|
20/04/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sakshi07sep@gmail.com].
- For how long will this data be available start date provided 03-02-2024 and end date provided 03-02-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
INTRODUCTION:-
A pragmatic
multimodal approach for adequate pain management and for early ambulation after
knee arthroplasty requires adductor canal blocks (ACB) or other regional
techniques. Choosing the right dose of local anesthetic agent (LA) in ACB for
pain management in knee arthroplasty is an important patient-centric decision. Inadequate
volume or concentration may lead to inadequate analgesia, increased opioid
consumption, and related morbidity and delayed discharge.Ropivacaine
has lower lipid solubility than Bupivacaine which is responsible for lower
penetration into myelinated motor fibers and thus less motor blockade. In view
of the reduced toxic potential, ropivacaine has a definite edge over
bupivacaine in regional anesthetic techniques requiring large volumes of local
anesthetic. AIMS
AND OBJECTIVES:- Aim of the study is to compare the analgesic efficacy of 0.125 % bupivacaine
and 0.2% ropivacaine infusion for
adductor canal block after total knee arthroplasty. Primary
object: -1) Analgesic efficacy (VAS score1-10) at different time interval; 10
is the worst pain. Secondary
objective – Total consumption of rescue analgesia STUDY PROCEDURE: - A prospective double blind randomized and comparative study will be conducted after approval from Institutional Ethical
Committee and with informed written consent, thirty-six patients of American
Society of Anesthesiologists (ASA) class I or class II of either sex, adult,
undergoing elective Total Knee Arthoplasty surgeries done under spinal
will be recruited. Patient will be given spinal anaesthesia. As per height &
weight 0.5 % bupivacaine will be given. At the end of the surgery Adductor Canal
Block will be given under ultrasound guidance by a trained qualified person by
using needle catheter set. After confirmation of proper deposition of drug at the
correct site, catheter will be introduced and fixed as per standard guide
catheter will be introduced and fixed as per standard guidelines. Patient will
be receiving study drug as per GROUP A AND GROUP B.GROUP A: Receiving 0.125% of Bupivacaine Infusion
@7ML/HR. GROUP B: Receiving 0.2% of Ropivacaine
Infusion @7ML/HR. All patients will receive Inj Paracetamol 100 ml TDS as per surgical
protocol.Patient will be monitored for vas score
along with the quadriceps muscle strength at the interval of 0. 1,2,4,8,12 and
24 hrs postoperatively If VAS score is
more than 5,infusion rate will be increased to 10 ml/hr, if still VAS score is
high patient will receive Inj.Tramadol 1mg per Kg intravenously. Total doses of rescue analgesics and side
effects like nausea , vomiting. bradycardia and hypotension will be noted. Statistical
analysis will be done by applying appropriate test. Both groups will be
compared for VAS score, quadriceps muscle strength, total doses of rescue
analgesics and side effects. With the time interval of Baseline, 1,2,4,6,8,12,24 HR of Intervals.
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