| CTRI Number |
CTRI/2021/07/035157 [Registered on: 27/07/2021] Trial Registered Prospectively |
| Last Modified On: |
23/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain relief options after total Knee Replacement. |
|
Scientific Title of Study
|
Comparison of Adductor canal block with local infiltration analgesia for post-operative pain management in total knee arthroplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHD JAVED KHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
jnmch amu aligarh |
| Address |
Department of Anaesthesiology and critical care.
JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8265955368 |
| Fax |
|
| Email |
jnmc.javed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NAZIA TAUHEED |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
jnmch amu aligarh |
| Address |
Department of Anaesthesiology and critical care,
JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7895330665 |
| Fax |
|
| Email |
naziatauheed15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHD JAVED KHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
jnmch amu aligarh |
| Address |
Department of Anaesthesiology and critical care,
JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8265955368 |
| Fax |
|
| Email |
jnmc.javed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care,
JNMCH, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CAREJNMCHAMU |
| Address |
Department of Anaesthesiology and critical care,JNMCH AMU ALIGARH
JNMCH, AMU, Aligarh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| MOHD JAVED KHAN |
JAWAHAR LAL NEHRU MEDICAL COLLEGE |
Department of Anaesthesiology and critical care,
JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH |
8265955368
jnmc.javed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ADDUCTOR CANAL BLOCK |
USG guided adductor canal block given and dose is (Bupivacaine 0.125% + Dexmedetomidine 0.5mcg/kg) |
| Comparator Agent |
Local Infilitration Analgesia (LIA) |
LIA with Wound infiltration (Bupivacaine 0.125% + Dexmedetomidine 0.5mcg/kg).
A total of 40ml of injectate is given.First, 10 ml of the drug would be injected just prior to implantation of the prosthesis, into the posterior aspect of the capsule and the medial & lateral collateral ligaments. Then, while the cement was curing, another 10ml would be infiltrated into the quadriceps mechanism and retinacular tissues. Another 10ml would be injected into the fat and subcuticular tissues. The remaining 10ml would be used infiltration of the incision line. This was done in the same manner for each knee. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I and II patients of either sex
2. Age between 18-75 years.
3. Weight between 55 -100 kg |
|
| ExclusionCriteria |
| Details |
1. Patients with mental dysfunction or cognitive deficiency.
2. Patients with neuro-muscular, vestibular, hepatic or major systemic disease.
3. History of psychiatric illness
4. History of alcohol or drug abuse
5. History of allergy to local anaesthetic
6. Medical conditions affecting balance and coordination
7. Patient who is not giving consent.
8. Neuropathies associated with disease condition, lesion, drugs etc |
|
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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 |
Primary Objective:
Pain relief assessment as
measuredd by
- Numerical Rating Scale (NRS) score changes |
Time to 1st perception of pain (NRS3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objective:
Time to 1st rescue analgesic requirement (NRS3)
Rescue analgesia needed in 1st 24 hours.
Overall patient satisfaction score.
Associated complications |
10 months |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2021 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE OF THESIS: Adductor Canal Block versus Local Infiltration Anelgesia & Wound infiltration for Post-operative pain management in Total Knee Arthroplasty. INTRODUCTION:Total knee arthroplasty (TKA), although a reliable and common surgical procedure to relieve pain and restore function, is associated with moderate to severe postoperative pain which can contribute to delayed rehabilitation. Reports suggest that short-term effective anaesthesia and analgesia can have long-lasting beneficial effects on recovery from surgery. The available interventions and management strategies for reducing and managing post – op pain after TKA include: Pre-emptive analgesia, local infiltration (Intraoperative peri-articular and extra-articular), systemic analgesics, neuraxial analgesia (Continuous epidural analgesia) and regional nerve blocks- single shot or continuous. LIA has been demonstrated to be equivalent to epidural anaesthesia with respect to postoperative analgesia, but superior in terms of improved mobilisation. Saphenous nerve block in the adductor canal (ACB) has been found to be equally effective as FNB with an advantage of selective sensory blockade and hence better ambulatory distance with lesser incidence of falls. |