| CTRI Number |
CTRI/2020/03/023919 [Registered on: 12/03/2020] Trial Registered Prospectively |
| Last Modified On: |
30/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare 2 types of regional nerve block saphenous and genicular nerve block with ultrasound machine in old age patients with knee pain in osteoarthritis. |
|
Scientific Title of Study
|
A study to compare efficacy of ultrasound guided saphenous versus genicular nerve block in osteoarthritis knee pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Zokarkar |
| Designation |
Post graduate student |
| Affiliation |
Pt. B. D. Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B. D. Sharma PGIMS, Rohtak
Department of anaesthesia, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
ashwinizokarkar22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susheela Taxak |
| Designation |
Senior Professor |
| Affiliation |
Pt. B. D. Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B. D. Sharma PGIMS, Rohtak
PGIMS CAMPUS, ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
susheelataxak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Susheela Taxak |
| Designation |
Senior Professor |
| Affiliation |
Pt. B. D. Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. B. D. Sharma PGIMS, Rohtak
PGIMS campus, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
susheelataxak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care,Pt.B.D.Sharma, PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Dr Ashwini Zokarkar |
| Address |
Department of Anaesthesiology and Critical Care,Pt.B.D.Sharma, PGIMS,Trauma center, Rohtak |
| Type of Sponsor |
Other [Self] |
|
|
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 Ashwini Zokarkar |
Pt.B.D.Sharma, PGIMS, Rohtak |
Department of Anaesthesiology and Critical Care 1st floor above MS Office, Surgery OT
Rohtak
HARYANA |
9425630450
ashwinizokarkar22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
| Comparator Agent |
Genicular nerve block |
Efficacy of ultrasound guided genicular nerve block in patients with osteoarthritis knee pain |
| Intervention |
Saphenous nerve block |
Efficacy of ultrasound guided saphenous nerve block in patients with osteoarthritis knee pain |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
History, examination and pain pattern consistent with osteoarthritis knee |
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity or allergy to local anaesthetic, steroids.
2. Patient with bleeding disorders.
3. Patient with infection at the site of block.
4. Previous history of genicular or saphenous nerve block, arthroscopic lavage and debridement of
knee joint.
5. Arthroscopic lavage and debridement of the knee joint.
6. Previous knee surgery.
7. Pregnant and lactating females.
8. Uncontrolled diabetes mellitus and hypertension.
9. Patient with history of cardiac, liver or kidney disease.
10. Patient with psychiatric illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To note the improvement in pain and disability using block. |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To note the ease of administration of block.
To note procedural complications, if any. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/03/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Comparison of the efficacy between 2 nerve blocks- saphenous and genicular ultrasound guided in patients with osteoarthritic knee pain was done. Both blocks are equally good in terms of improvement in pain score, physical status, patient satisfaction and number of nerve block. Both these techniques provide good pain relief and improvement in physical disability to the patients at all-time interval of our study. |