| CTRI Number |
CTRI/2024/07/070562 [Registered on: 13/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A trial of blocking pain around knee joint by alcohol or phenol based intervention. |
|
Scientific Title of Study
|
Efficacy of USG guided genicular nerve block with aqueous phenol(6%),ethyl alcohol(95%) and triamcinolone(20mg)with lignocaine(2%)-a randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIBEDITA MALIK |
| Designation |
Junior resident |
| Affiliation |
Nil Ratan Sircar Medical College and Hospital |
| Address |
Department of Physical Medicine and Rehabilitation Nil Ratan Sircar Medical College and Hospital Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
6294785683 |
| Fax |
|
| Email |
dr.nibeditamalik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SAUMEN KUMAR DE |
| Designation |
Associate Professor |
| Affiliation |
Nil Ratan Sircar Medical College and Hospital |
| Address |
Department of Physical Medicine and Rehabilitation Nil Ratan Sircar Medical College and Hospital Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
9433124596 |
| Fax |
|
| Email |
drsaumen16@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
NIBEDITA MALIK |
| Designation |
Junior resident |
| Affiliation |
Nil Ratan Sircar Medical College and Hospital |
| Address |
Department of Physical Medicine and Rehabilitation Nil Ratan Sircar Medical College and Hospital Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
6294785683 |
| Fax |
|
| Email |
dr.nibeditamalik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil Ratan Sircar Medical College and Hospital Sealdah Kolkata Pin 700014 West Bengal India |
|
|
Primary Sponsor
|
| Name |
Nil Ratan Sircar Medical College and Hospital |
| Address |
138 Acharya Jagadish Chandra Bose Road Sealdah Raja Bazar
Kolkata 700014 West Bengal |
| 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 |
| NIBEDITA MALIK |
Nil Ratan Sircar Medical College |
Department of Physical Medicine and Rehabilitation Elliot Building Ground Floor Room no 1
Kolkata
WEST BENGAL |
6294785683
dr.nibeditamalik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NRS MEDICAL COLLEGE |
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 |
USG guided genicular nerve block |
USG guided genicular nerve block in three sites namely superomedial superolateral and inferomedial area of knee joint with 3 ml aqueous phenol 6% on each site, 3 ml ethyl alcohol 95% on each site and triamcinolone 20 mg with lignocaine 2% total 3 ml on each site for single intervention and will be reviewed on 0 week baseline 4th week 12th week 24th week post intervention with total duration of study 18 months including recruitment of participants to result analysis |
| Comparator Agent |
USG guided genicular nerve block |
Participants will be allocated in any of the following three groups
one group will receive genicular nerve block with 6% aqueous phenol second group will receive genicular nerve block with 95% ethyl alcohol and the participants of the third group will receive genicular nerve block with 20mg triamcinolone with 2% lignocaine each group will act as comparator for the other |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients from out patient department during the study primary osteoarthritis knee age between 40 to 60 years both gender clinically and radiologically confirmed for at least 3 months of duration |
|
| ExclusionCriteria |
| Details |
Patients with secondary osteoarthritis knee grade I and II osteoarthritis knee KL grading patients with uncontrolled comorbidities patients who got intraarticular injection in knee joint within last 3 months patients of syndrome complex not willing to give consent with psychiatric disorder of malignancy of bleeding diathesis with history of allergy of any of the pharmacological agents with infection either systemic or local history of knee surgery with anticoagulant medications |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
General Objective is to evaluate reduction of pain in VAS Scale in grade III and grade IV osteoarthritis Knee as per KL grading
Specific Objectives are to assess the improvement in knee pain and quality of life in KOOS Scale to find out the improvement in the sleep quality in Pittsburgh sleep quality index PSQI scale to identify the side effects if any due to intervention
|
outcome will be assessed at baseline or 0 week 4th week 12th week and at 24th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in knee pain quality of life in KOOS Scale to find out the improvement in sleep quality in Pittsburgh sleep quality index PSQI scale to identify the side effects if any due to intervention |
Outcome will be assessed at baseline or 0 week 4th week 12th week 24th week |
|
|
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)
|
22/08/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Osteoarthritis knee (OA knee) causes significant
pain and disability in the aged population. Increasing trend in prevalence data
of OA Knee in the Indian
subcontinent needs urgent, specific management protocol to reduce the morbidity
of the patient, caregivers’ burden, and socio-economic burden. With
increasing grading of OA knee; there is increasing chances of disability,
decreasing pain control, increasing pill burden of patients, and increasing
medication related side effects also and many of them don’t want to undergo for
surgery or otherwise contraindicated for surgical intervention. The present
study aims to describe the role of genicular nerve block by 6% aqueous phenol,
95% ethyl alcohol and triamcinolone 20 mg with 2% lignocaine, under USG
guidance in treatment of Grade III and Grade IV OA knee. As there are scarcity
of evidences of newer methods of treatment, its practical implications, and
head to head study of newer agents are also lacking; hence this is our humble
approach. |