| CTRI Number |
CTRI/2024/12/078158 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [pain relief intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Pain Relief in Knee Osteoarthritis: Thermal Radiofrequency Ablation with Ultrasound-Guided i-PACK Block Using Classical vs. Revised Targeting Techniques |
|
Scientific Title of Study
|
"To compare the effect of thermal radiofrequency ablation of the genicular nerves, along with ultrasound-guided i-PACK block, in providing pain relief in patients with osteoarthritis of the knee joint, using the classical versus revised target technique." |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANUPAM SHARMA |
| Designation |
Assistant Professor |
| Affiliation |
dr Yashwant Singh Paramar Govt medical college Nahan |
| Address |
Assistant Professor, Department of Anaesthesia, Dr. Yashwant Singh Parmar Government Medical College and Hospital, Nahan, Sirmaur, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173001
India |
| Phone |
09418031481 |
| Fax |
|
| Email |
drsharma3105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANUPAM SHARMA |
| Designation |
Assistant Professor |
| Affiliation |
dr Yashwant Singh Paramar Govt medical college Nahan |
| Address |
Assistant Professor, Dept of Anaesthesia, Dr Yashwant Singh Parmar Government Medical College and Hospital, Nahan, Sirmour, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173001
India |
| Phone |
09418031481 |
| Fax |
|
| Email |
drsharma3105@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANUPAM SHARMA |
| Designation |
Assistant Professor |
| Affiliation |
dr Yashwant Singh Paramar Govt medical college Nahan |
| Address |
Assistant Professor, Department of Anaesthesia, Dr. Yashwant Singh Parmar Government Medical College and Hospital, Nahan, Sirmaur, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH
173001
India |
| Phone |
09418031481 |
| Fax |
|
| Email |
drsharma3105@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Dr. Yashwant Singh Parmar Government Medical College and Hospital, Nahan, district Sirmaur, Himachal Pradesh 173001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Anupam Sharma |
dr Yashwant Singh Parmar Government medical college Nahan |
Assistant Professor, Department of Anaesthesia,operation theater complex in Pain OT, Dr. Yashwant Singh Parmar Government Medical College and Hospital, Nahan, Sirmaur, Himachal Pradesh
Sirmaur
HIMACHAL PRADESH |
9418031481
drsharma3105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| dr Yashwant Singh Parmar Government medical college Nahan |
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 |
GROUP I .Classical anatomical target approach group (n) |
The knee joint will be palpated, needle insertion site will be marked with C-Arm guidance and the entry point skin will be anesthetized with 1% lidocaine. A radiofrequency cannula with 22 G 100-mm length and 10-mm active tip will be used for the procedure. The nerve targeted includes superior lateral genicular nerve, superior medial genicular nerve and the inferior medial genicular nerve along with i-PACK in both the groups. The procedure will be carried out using Radio frequency PMG advanced Halyard Health, USA version 4.2A for sensory and motor stimulation prior to the procedure and also used for the radio frequency genicular nerve ablation.
Radiofrequency cannula will be placed extra-articularly around the knee joint with classical anatomical targets approach under C-Arm guidance. After satisfactory placement, the stylet in the cannula is removed and RF probe (PMG advanced Halyard Health, USA version 4.2A) will be placed through the cannula and motor (2 hz and 0.5 V) and sensory (50 Hz and 0.2 V) stimulation will be done. After localizing the Genicular nerve, 1 ml of 1% lidocaine will be
given at each needle site and wait for two minutes. Radiofrequency will be given at 70 degree Celsius for two cycles each of 1.5 minutes duration followed by ultrasound guided i-PACK block.
|
| Intervention |
GROUP II Revised anatomical target approach group (R) |
A single, experienced interventionist will perform all the interventions as per group assigned on opening the sealed envelopes. The randomization sequence was concealed from participants as well as the investigator monitoring the participants throughout the study. (Neither participants nor the investigator will be aware of the assigned interventions). Radiofrequency cannula will be placed extra articularly around the knee joint using revised anatomical target approach under C-Arm guidance. After satisfactory placement, the stylet in the cannula is removed and RF probe (PMG advanced Halyard Health, USA version 4.2A) will be placed through the cannula and motor (2 hz and 0.5 V) and sensory (50 Hz and 0.2 V) stimulation will be done. After localizing the Genicular nerve, 1 ml of 1% lidocaine will be given at each needle site and wait for two minutes. Radiofrequency will be given at 70 degree Celsius for two cycles each of 1.5 minutes duration. Following conventional Radio frequency ablation ultrasound guided i-PACK will be given to the cases.
In case there is no sensory response seen in revised or classical landmark technique, we will reposition the needle till we get the desired sensory response and this new location will be noted and will be interpreted at the end of the study.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with stage 1, 2 and Stage 3 of Kellgren-Lawrence classification based on X-ray knee joint
2. Criteria age from 40 to 70 years
3. Pain localized to knee joint with no referred pain or any other cause of knee pain
4. Patients without visible gross structural deformity of the knee joint
5. Patients with American Society of Anaesthesiologists Grade I and II
6. patients with Visual Analogue Scale more than 4
7. Patients on conservative treatment such as physical therapy, analgesic drugs including NSAIDs or opioids, for at least six months.
|
|
| ExclusionCriteria |
| Details |
• Patient refusal
• Patient’s with gross deformity of the knee joint or associated tendon pain and bursitis.
• Existence of general contraindications against application of invasive intervention (such as hemorrhagic diathesis, on antiplatelets and anticoagulant therapy, systemic infection, or local infection at the area to be intervened and patient with pacemakers
• Psychiatric disorders and drug dependence/abuse
• Acute knee pain and prior knee surgeries.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the effect of thermal Radio frequency of the genicular nerve along with ultrasound guided i-PACK block in providing pain relief in patients of osteoarthritis of the knee joint using classical versus the new revised target technique |
post procedure , 1, 4, 8,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To compare the total analgesic intake in both patient groups throughout the observation period. |
post procedure, 1 , 4, 8, 12 weeks |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="2"
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
|
this study will involve clinically diagnosed patients of osteoarthritis knee joint from 1st January 2025 for next two years. they will be randomly assigned into two groups of group I is classical anatomical target approach and group II is revised anatomical target approach. the procedure will be done under C-arm guided radiofrequency ablation of genicular nerves followed by with USG guided i-pack block given in both the groups. Pain relief will be assesd by VAS at 1,2,4,8 weeks. in case if any complication patient will be excluded from the study. |