| CTRI Number |
CTRI/2024/04/065041 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to determine USG changes in Knee Osteoarthritis and Effect of Genicular nerve block |
|
Scientific Title of Study
|
A Prospective Observational Study To Correlate The Ultrasonographical Changes Of Knee Joint In Patient With Knee Osteoarthritis With Clinical Findings And To Assess Their Response To USG Guided Genicular Nerve Block In Patients Of Knee Osteoarthritis Coming To Pain OPD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta Bhagat |
| Designation |
Junior Resident |
| Affiliation |
Lokmanya Tilak Municipal General Hospital |
| Address |
Department of Anesthesiology,College Building,4th floor,Lokmanya Tilak Municipal General Hospital,Sion,Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
8108639565 |
| Fax |
|
| Email |
bhagatmamta06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilam Virkar |
| Designation |
Associate Professor |
| Affiliation |
Lokmanya Tilak Municipal General Hospital |
| Address |
Department of Anesthesiology,4th Floor,College Building,Lokmanya Tilak Municipal General Hospital,Sion,Mumbai,Maharashtra.
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
7506355637 |
| Fax |
|
| Email |
virkarnilam83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilam Virkar |
| Designation |
Associate Professor |
| Affiliation |
Lokmanya Tilak Municipal General Hospital |
| Address |
Department of Anesthesiology,College building 4th floor,Lokmanya Tilak Municipal General Hospital,Sion,Mumbai
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
7506355637 |
| Fax |
|
| Email |
virkarnilam83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical College and General Hospital |
|
|
Primary Sponsor
|
| Name |
Mamta Bhagat |
| Address |
Junior Resident Lokmanya Tilak Municipal General Hospital and Medical College Department of Anaesthesia, Room 401,Sion Mumbai |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nilam Virkar |
LTMMC and LTMGH |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mamta Bhagat |
Lokmanya Tilak Municipal General Hospital And Medical College |
Department of Anaesthesia Coll Building 4th Floor,Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
8108639565
bhagatmamta06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Research Lokmanya Tilak Municipal Medical College and General 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
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients with Knee pain diagnosed as primary Knee Osteoarthritis receiving Genicular Nerve block as treatment modality will be included in the study.
Patient willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Patient diagnosed with secondary Knee Osteoarthritis and Knee pathology due to systemic or local inflammatory diseases(rheumatoid arthritis or other inflammatory arthropathies)
Intake of steroids in last four weeks prior the study entry
Patient not giving consent to participate in study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Document the postprocedure analgesia using WOMAC and VAS scoring System |
Document the postprocedure analgesia using WOMAC and VAS scoring System at 1hor,1week and 1month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Osteoarthritic Knee Ultrasonographically to assess the changes of Osteoarthritis and to Correlate it with Xray KL grading,Clinically with VAS sore WAS Score |
Before giving the Genicular Nerve block to the patient |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/04/2024 |
| 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="1"
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 - NO
|
|
Brief Summary
|
After confirming the inclusion and exclusion criteria and taking a valid written consent,patient will be taken to pain OT,a pre procedure USG scan of knee will be done to correlate the changes of primary knee osteoarthritis with the severity of the Xray findings using the K-L radiological scores,and to determine if there’s a significant correlation between USG changes and the pain intensity measured by VAS and functioning scores with WOMAC questionnaire along with clinical examination findings. Post scan USG guided Genicular Nerve block is given using 0.25- 0.5% Ropivacaine in a volume of 4-5ml per nerve ,patient will be followed up for a period of 1 month post procedure at regular intervals to assess the efficacy of genicular nerve block in decreasing the VAS and WOMAC score in knee osteoarthritis patient coming to pain OPD. |