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

February 21, 2025 updated by: Ain Shams University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

the study measures the efficacy of genicular nerves cooled radiofrequency ablation in enhancing quality of rehabilitation in patients undergoing total knee replacement

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Recruiting
        • Faculty of Medicine Ain Shams University
        • Contact:
        • Contact:
          • Ahmed Koraitim, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:• Undergoing a scheduled unilateral total knee replacement surgery

-

Exclusion Criteria:

  • • Allergy to any of the drugs used in the study

    • Alcohol or drug abuse
    • Psychiatric disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lumber epidural anesthesia
Patients will receive epidural anesthesia intra operative
Procedure: Epidural
Patients will receive epidural anesthesia intra operative and epidural analgesia post-operative
Experimental: lumber Epidural and unilateral genicular nerve ablation:
Patient will receive lumber epidural anesthesia and unilateral genicular nerve cooled radio frequency ablation pre-operative
Procedure: Epidural
Patients will receive epidural anesthesia intra operative and epidural analgesia post-operative
Procedure: unilateral Radiofrequency
unilateral genicular nerve cooled radio frequency ablation pre-operative
Experimental: Epidural and bilateral genicular nerve ablation
Patient will receive lumber epidural anesthesia and bilateral genicular nerve cooled radio frequency ablation pre-operative
Procedure: Epidural
Patients will receive epidural anesthesia intra operative and epidural analgesia post-operative
Procedure: bilateral Radiofrequency
bilateral genicular nerve cooled radio frequency ablation pre-operative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
o Epidural rescue doses
Time Frame: 1st 48 hours
rescue doses reflects degree of pain control
1st 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Estimated)

April 13, 2025

Study Completion (Estimated)

June 13, 2025

Study Registration Dates

First Submitted

October 19, 2024

First Submitted That Met QC Criteria

October 19, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R221/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data required for interpretation of results will be shared

IPD Sharing Time Frame

6 months to 12 months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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