Ultra Sound Guided Genicular Nerves Cooled Radiofrequency Ablation in Total Knee Replacement Surgeries

NCT06651762 | Recruiting

• 1 other identifier: FMASU R221/2024
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Total Knee Replacement surgery is common procedure that is usually done for patients suffering from persistent pain with limitation of movement. Unfortunately, they do suffer after the operation as it is associated still with significant pain that affect the rehabilitation plan, hospital length of stay, life style and patient satisfaction. New approaches are rising every day to add to the multimodal management plan. Genicular nerves cooled radiofrequency ablation is a new approach that can be simply done U.S. guided with little side effects, if any, and great results.

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• o Epidural rescue doses

  rescue doses reflects degree of pain control

  1st 48 hours

Study Arms (3)

lumber epidural anesthesia

EXPERIMENTAL

Patients will receive epidural anesthesia intra operative

Procedure: Epidural

lumber Epidural and unilateral genicular nerve ablation:

EXPERIMENTAL

Patient will receive lumber epidural anesthesia and unilateral genicular nerve cooled radio frequency ablation pre-operative

Procedure: unilateral Radiofrequency; Procedure: Epidural

Epidural and bilateral genicular nerve ablation

EXPERIMENTAL

Patient will receive lumber epidural anesthesia and bilateral genicular nerve cooled radio frequency ablation pre-operative

Procedure: bilateral Radiofrequency; Procedure: Epidural

Interventions

unilateral Radiofrequency PROCEDURE

unilateral genicular nerve cooled radio frequency ablation pre-operative

lumber Epidural and unilateral genicular nerve ablation:

bilateral Radiofrequency PROCEDURE

bilateral genicular nerve cooled radio frequency ablation pre-operative

Epidural and bilateral genicular nerve ablation

Epidural PROCEDURE

Patients will receive epidural anesthesia intra operative and epidural analgesia post-operative

Epidural and bilateral genicular nerve ablation; lumber Epidural and unilateral genicular nerve ablation:; lumber epidural anesthesia

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Allergy to any of the drugs used in the study
• Alcohol or drug abuse
• Psychiatric disease

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of medicine Ain Shams University

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Abdallah soudi, M.D.

CONTACT

+201111228925; dr.soudi2014@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 22, 2024
• Study Start: October 14, 2024
• Primary Completion: April 13, 2025
• Study Completion: June 13, 2025
• Last Updated: February 24, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months to 12 months after publication

Locations

EG (1)