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CTRI Number  CTRI/2024/05/068225 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 23/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of ultrasound guided pulsed radiofrequency treatment of saphenous nerve and genicular nerve block for treatment of knee joint osteoarthritis pain. 
Scientific Title of Study   Comparative evaluation of ultrasound guided pulsed radio frequency treatment of saphenous nerve and genicular nerve block vs genicular nerve block alone for patients with knee joint osteoarthritis pain: a prospective randomized study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandeep Khuba 
Designation  Additional Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
Address  Department of Anaesthesiology, SGPGIMS, Raibareli Road, Lucknow-226014, Uttar Pradesh

Lucknow
UTTAR PRADESH
226014
India 
Phone  9984242707  
Fax    
Email  sandeepkhuba@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sandeep Khuba 
Designation  Additional Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
Address  Department of Anaesthesiology, SGPGIMS, Raibareli Road, Lucknow-226014, Uttar Pradesh

Lucknow
UTTAR PRADESH
226014
India 
Phone  9984242707  
Fax    
Email  sandeepkhuba@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anshika Singh 
Designation  Postgraduate student  
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
Address  Department of Anaesthesiology, SGPGIMS, Raibareli Road, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8887970077  
Fax    
Email  singhanshika770@gmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raibareli Road, Lucknow-226014, Uttar Pradesh , India 
 
Primary Sponsor  
Name  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
Address  Raibareli Road, Lucknow 226014 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Khuba  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow  Roome no 32, Pain Clinic, Department of Anaesthesiology, Raibareli Road, Lucknow-226014, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 		 9984242707

sandeepkhuba@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SGPGIMS, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (3) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (4) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound guided Knee genicular nerves block  The Ultrasound guided genicular block will be performed in the procedure room of the pain clinic under all aseptic precautions with monitored anaesthesia care. The affected knee will be placed in a slightly flexed position with a pillow underneath. A high frequency linear US probe (6-13 MHz) (M-Turbo, Fujifilm Sonosite, USA) will be prepared for aseptic use and placed longitudinally along the length of the femur, first on the superomedial aspect, such that the shaft of the femur, the medial femoral condyle and the junction were clearly visualized (Figure 1). The probe then will be tilted or moved in the longitudinal plane medially to laterally to locate the superomedial genicular artery. The artery will be visualized in the cross-sectional view and was seen as a pulsatile structure just at the junction of the shaft and the condyle, close to the periosteum. If multiple small arteries are visualized, the one closest to the shaft-condyle junction and lying just above the periosteum will be selected (Figure 2). A 26 G 1 ½ inch hypodermic needle (Romsons, India) then will be inserted in an out-of-plane manner to reach the artery identified. Once the needle reached the desired target and in contact with bone, it will be withdrawn by 1-2mm, and 1 ml of 0.5% bupivacaine with 1mg Dexamethasone will be injected after negative aspiration for blood. The injectate will be seen to spread in a lenticular fashion just superficial to the periosteum, surrounding the artery. The genicular nerve lies in the same neurovascular bundle close to the artery and hence it will be assumed to be covered by the local anaesthetic. The superolateral nerve will be blocked in a similar manner placing the probe longitudinally along the superolateral aspect of the femur. For the inferomedial genicular nerve, the probe will be placed over the medial aspect of the tibia and the drug will be deposited around the artery located at the junction of the tibial shaft and condyle. 
Intervention  Ultrasound guided pulsed radiofrequency treatment of saphenous nerve with knee genicular nerve block  The Ultrasound pulsed radiofrequency treatment of saphenous nerve will be performed in the procedure room of the pain clinic under all aseptic precautions with monitored anaesthesia care. The patient will be positioned supine on the operating table. The leg on the affected side will be slightly abducted. The parts will be aseptically prepared. A high frequency linear US probe (6-13 MHz) (M-Turbo, Fujifilm Sonosite, USA) will be prepared for aseptic use. The US probe will be placed at middle of the thigh to identify the adductor canal. The saphenous nerve will be identified as a round hyperechoic structure anterolateral to femoral artery and vein in the adductor canal in sub-sartorial plane. The skin and subcutaneous tissue will be anaesthetized with 2-3 ml of 1% lidocaine. A 22 G, 10 cm radiofrequency needle with 5 mm active tip will be inserted in-plane close to saphenous nerve. Sensory and motor stimulation will be done to confirm the proximity to the saphenous nerve. The sensory stimulation (50 Hz) up to 0.5 V and absent motor stimulation (2 Hz) in the distribution of saphenous nerve will confirm the location of saphenous nerve. The 4 cycles of pulse radiofrequency at 42ºC and 45 V for 120 second each will be given after giving 5 ml of 1% lidocaine. The sterile dressing will be applied, and the patient will be observed in post anaesthesia care unit for 2 hrs.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with complaints of knee pain of osteoarthritis origin (Kallgren Lawrence grade 2-4)
Patients who failed conservative treatment for at least 3 months.
 
 
ExclusionCriteria 
Details  The patients with a history of knee surgery, trauma, or any inflammatory systemic diseases.
Patients with history of corticosteroid therapy in last 3 months.
Patients not willing for follow-up.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS (Visual Analogue Scale) score: VAS score for pain is calculated using a 0 to 10 cm horizontal line, where 0 corresponds to no pain and 10 to severe pain. The patient is asked to mark his or her current pain on this line. The point where the patient has marked on this line is measured and reported as the score. The validated Hindi version of VAS scores will be used for the patients who do not understand English language.

WOMAC (Western Ontario McMaster Universities Osteoarthritis Index) score: The WOMAC score is calculated by patient reporting it’s score in three categories: pain (five questions, possible subscale scores 0–20), stiffness (two questions, 0–8), and physical functioning (17 questions, 0–68), with a minimum score of 0, and a maximum score of 96. The validated Hindi version of WOMAC scores will be used for the patients who do not understand English language.
 		 Pre-procedure and 1 week, 1 month, 3-month, 6-month and 12-month post-procedure 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 4 
Date of First Enrollment (India)   01/07/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sandeepkhuba@gmail.com].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 31-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Osteoarthritis of the knee joint is a troublesome disease particularly in the elderly population. It is characterized by pain and stiffness of the knee joint. its management include lifestyle modifications, use of paracetamol, non-steroidal anti-inflammatory disease, and total knee replacement in resistant cases. Interventional treatment employs the use of nerve blocks and intraarticular supplementation to provide pain relief to these patients. The knee joint is supplied by genicular branches of femoral, tibial, common peroneal, saphenous and obturator nerves. Genicular nerve blocks have been used in these patients with satisfactory short-term outcomes. Pulsed radiofrequency of peripheral nerves is being utilized to enhance the analgesic efficacy of nerve blocks. The present study hypothesizes that combination of pulsed radiofrequency of saphenous nerve and genicular nerve block is better than genicular nerve block alone to relieve the pain of knee joint osteoarthritis. This study will be conducted in 60 patients divided randomly into 2 equal groups of 30 each. One group will be given combined pulsed radiofrequency of saphenous nerve and genicular nerve block and another group genicular nerve block alone. The pulsed radiofrequency of the saphenous nerve will be done at 42⁰C and 45 V for 8 minutes under ultrasound guidance. The ultrasound guided genicular nerve block of 3 nerves i.e.  superomedial, superolateral and inferomedial genicular nerves will be done with 1 ml of 0.5% bupivacaine.  These patients will be evaluated with visual analogue score (VAS) and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) score at baseline, 1 week, 1 month, 3-month and 6-month post procedure to assess the efficacy of the procedures. Any adverse effects experienced by the patients will also be recorded during the study period.

 
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