| CTRI Number |
CTRI/2020/12/029705 [Registered on: 10/12/2020] Trial Registered Prospectively |
| Last Modified On: |
03/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
What is better for patients with chronic knee osteoarthritis?Ultrasound Guided Genicular Nerve Block using 0.5% bupivacaine in
Combination with Intra-Articular Platelet Rich Plasma Protein or Intra-Articular Steroids ? |
|
Scientific Title of Study
|
Comparison of Ultrasound Guided Genicular Nerve Block using 0.5% bupivacaine in
Combination with Intra-Articular Platelet Rich Plasma Protein and Intra-Articular Steroids among
Patients with Chronic Knee Osteoarthritis – A Triple Blinded Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sivabalakumaran Kengadaran |
| Designation |
Post graduate |
| Affiliation |
Department of Anesthesia, Chengalpattu government medical college |
| Address |
Chengalpattu government medical college, VOC Nagar, Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9600994850 |
| Fax |
|
| Email |
k.sivabalakumaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mala R |
| Designation |
Associate Professor |
| Affiliation |
Department of Anesthesiology, Chengalpattu Government Medical College |
| Address |
Chengalpattu government medical college, VOC Nagar, Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
|
| Fax |
|
| Email |
statzwizz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sivabalakumaran Kengadaran |
| Designation |
Post Graduate |
| Affiliation |
Department of Anesthesia, Chengalpattu Government Medical College |
| Address |
Chengalpattu government medical college, VOC Nagar, Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9600994850 |
| Fax |
|
| Email |
k.sivabalakumaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chengalpattu Government Medical College |
|
|
Primary Sponsor
|
| Name |
Sivabalakumaran |
| Address |
Medical College, VOC Nagar, Chengalpattu, Tamil Nadu 603001 |
| Type of Sponsor |
Other [Individual Person] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sivabalakumaran |
Medical College |
Medical College, VOC Nagar, Chengalpattu, Tamil Nadu 603001
Kancheepuram
TAMIL NADU |
960099450
k.sivabalakumaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Chengalpattu Government Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5% bupivacaine in Combination with Intra-Articular Platelet Rich Plasma Protein |
Single dose of 0.5% bupivacaine in Combination with Intra-Articular Platelet Rich Plasma Protein is administered during ultrasound guided genicular nerve block. Patients will be followed up at different time intervals i.e., 1, 2, 4 and 8 weeks after Genicular Nerve Block |
| Comparator Agent |
0.5% bupivacaine in Combination with Intra-Articular Steroids |
Single dose of 0.5% bupivacaine in Combination with Intra-Articular Steroids is administered during ultrasound guided genicular nerve block. Patients will be followed up at different time intervals i.e., 1, 2, 4 and 8 weeks after Genicular Nerve Block |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged 50–80 years with knee pain of moderate or greater intensity on most or all days
for ≥ 3 months and radiological tibiofemoral OA (Kellgren-Lawrence grade 2–4 as evaluated
by a radiologist). |
|
| ExclusionCriteria |
| Details |
1. Subjects with acute knee pain
2. Subjects who underwent prior knee surgery or electropuncture treatment
3. Subjects with other connective tissue diseases that affected the knee, serious neurological or
psychiatric disorders
4. Subjects under steroid or hyaluronic acid injection therapy during the previous 3 months
5. Subjects with sciatic pain, anticoagulant medication use and pacemaker use |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain using Visual Analog Scale (VAS)
|
1, 2, 4, and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional changes in the knee using Oxford Knee Scores (OKS)
Patient satisfaction with treatment using Global Perceived Effects and
Incidence of adverse effects. |
1, 2, 4, and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2021 |
| 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="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Summary Osteoarthritis is a progressive, degenerative process that affects joint cartilage and the subchondral bone. There are many different conservative treatments or minimally invasive treatments offered for patients with knee osteoarthritis. Several studies have reported the successful performance of GNB under ultrasound guidance. Literature suggests that GNB, when administered together with a corticosteroid, is as effective as RF genicular ablation. It is already known that Platelet-rich plasma protein (PRP) contains cytokines and growth factors that are capable of stimulating cellular growth, vascularization, proliferation, tissue regeneration, and collagen synthesis. However, there is paucity in literature with regard to the efficacy of genicular nerve block when administered with PRP on pain reduction. Hence the study was planned to compare the effectiveness of Ultrasound-Guided Genicular Nerve Block using 0.5% bupivacaine in Combination with Intra-Articular Platelet Rich Plasma Protein and Intra-Articular Steroids among Patients with Chronic Knee Osteoarthritis Population: Patients with chronic knee pain Intervention: Administration of 0.5% bupivacaine plus PRP during ultrasound-guided genicular nerve block. Comparison: Administration of 0.5% bupivacaine with steroids during ultrasound-guided genicular nerve block. Outcome: a) Primary outcome is to assess the mean changes from baseline levels of knee pain to 1, 2, 4, and 8 weeks after GNB, as measured using Visual Analog Scale (VAS) b) Secondary outcomes are the assessment of functional changes in the knee, patient satisfaction with treatment, and the incidence of adverse effects. Time: Patients will be followed up at different time intervals i.e., 1, 2, 4 and 8 weeks after Genicular Nerve Block |