| CTRI Number |
CTRI/2025/10/096559 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of nerve block around knee joint in reducing symptoms of osteoarthritis knee |
|
Scientific Title of Study
|
The effectiveness of Ultrasound-guided three-needle approach of genicular nerve block in improving pain, functionality and quality of life in patients suffering from chronic knee osteoarthritis: A prospective observational study |
| Trial Acronym |
USGNB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lt Col Dr Mohit Kataruka |
| Designation |
Assosciate Professor |
| Affiliation |
AIIMS, Kalyani |
| Address |
Room 115, Ground Floor, OPD Building, AIIMS Kalyani.
NH-34 Connector, Basantapur, Saguna, Kalyani, Nadia, West Bengal, 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
8729912916 |
| Fax |
|
| Email |
mohit.pmr@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Souvik Bhattacharjee |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Kalyani |
| Address |
Room 117, Ground Floor, OPD Building, AIIMS Kalyani.
NH-34 Connector, Basantapur, Saguna, Kalyani, Nadia, West Bengal, 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
7044544347 |
| Fax |
|
| Email |
souvik.vicky@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Souvik Bhattacharjee |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Kalyani |
| Address |
Room 117, Ground Floor, OPD Building, AIIMS Kalyani.
NH-34 Connector, Basantapur, Saguna, Kalyani, Nadia, West Bengal, 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
7044544347 |
| Fax |
|
| Email |
souvik.vicky@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Kalyani |
| Address |
NH-34 Connector,Basantapur, Saguna, KAlyani, Nadia, 741245 |
| 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 Souvik Bhattacharjee |
AIIMS Kalyani |
Department of Physical Medicine and Rehabilitation, Room 117. Ground Floor, OPD building.
Nadia
WEST BENGAL |
7044544347
souvik.vicky@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided genicular nerve block |
Ultrasound guided three point genicular block will be given at superomedial and lateral, and infero-lateral genicular nerves using 5 ml of 0.5% Bupivacaine, 2 ml of 2 % Lignocaine, 1 ml of Triamcinolone acetonide (40 mg) with 4-5 ml of NS |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed case of osteoarthritis knee according to American college of rheumatology criteria (ACR)
2.Radiographic Kellgren-Lawrence grade 3 and 4
3.Knee pain with pain intensity of more or equal to 4 of 10 in visual analog scale, most of the days for last three months , refractory to conservative management. |
|
| ExclusionCriteria |
| Details |
1. Severe neurological or psychiatric diseases
2. History of any steroid injection within 3 months
3. Previous knee surgeries (unicompartmental or total arthroplasty, debridement arthroscopy, osteotomies)
4. Persons using anticoagulants or with bleeding disorders
5. Persons with uncontrolled diabetes and hypertension
6. Any history of allergy, or superficial skin infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analog Scale |
Baseline , after 2 weeks, after 4 weeks, after 8 weeks and after 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Western Ontario and McMaster Universities |
2 weeks, 4 weeks, 8 weeks and 4 months |
| Knee injury and osteoarthritis outcome score |
2 weeks, 4 weeks, 8 weeks and 4 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
03/11/2025 |
| 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 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 (OA) of the knee joint is one of the
common joint degenerative diseases affecting almost 12 % of the population over
their sixties. Approximately 70-80% of the affected individuals are
sixty-five or older. Knee OA is a chronic joint disease leading to pain,
disability and hamper daily activities of the patients, which ultimately leads
to significant social impairments and healthcare burden worldwide.
Both non-surgical and
surgical methods are available for the management of OA knees. In non-surgical
options, we have patient education, lifestyle modification, physical therapies,
bracing, and pharmacological management. Different types of injections like
intra-articular steroid, prolotherapy, Ozone, platelet-rich plasma (PRP),
hyaluronic acid are also available. A few recent interventions are stem cell
therapy, genicular nerve block; all of which are aimed to reduce the symptoms,
improve the functionality of the affected individuals. In severe cases,
only surgical management is the remaining option, i.e. partial or total knee
arthroplasty.
In case of severe OA knee, Kellgren-Lawrence grade 4
surgery is required. The majority of the interventions are rendered ineffective
in severe OA knee. Therefore, this study aims to evaluate the effectiveness of genicular
nerve block in cases of severe OA kneeWe hypothesized that there would be improvement in
cases of severe OA knee in the domains of pain and functionality.
|