Comparison Between Percutaneous Femoral Nerve Neuromodulation Associated With Femoral Nerve Block and Standard Clinical Practice in Patients Undergoing Knee Arthroplasty. (NEPFAR)

July 24, 2023 updated by: FERRAN MARQUES PEIRO, Hospital General Universitario de Valencia

Percutaneous Femoral Nerve Neuromodulation for Postoperative Analgesia and Functional Recovery Following Knee Arthroplasty.

The goal of this clinical trial is to compare the maximum isometric contraction force differential of the quadriceps in the postoperative period after the use of a peripheral nerve neuromodulation program in patients undergoing knee arthroplasty. The main questions it aims to answer are if the combination of a peripheral neuromodulation program in the perioperative period improves analgesic quality and short-term functional recovery in patients undergoing knee arthroplasty,

Participants will be asked to reach a maximum knee extension prior to neurostimulation Patients will have the electrodes inserted under direct ultrasound vision and placed near the femoral nerve.

Researchers will compare whether there is a difference in both quadriceps contraction force and analgesia between the stimulated group and the control group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

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 Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46020
        • Recruiting
        • Hospital General Universitario de Valencia
        • Contact:

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:

  • Over 18 years
  • Those who sign the informed consent
  • Not pregnant
  • Cognitive capacity that allows subjective postoperative evaluations.

Exclusion Criteria:

  • Under 18 years old
  • IC rejection or withdrawal
  • Pregnancy
  • Cognitive impairment
  • Contraindication for Regional Anesthesia

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuromodulation group

The maximum isometric contraction force of the quadriceps will be measured prior to the neuromodulation program using a hand dynamometer.

The percutaneous neuromodulation program will begin using the EPTE® Bipolar System device. The two stimulation protocols will be applied consecutively. Firstly, the high-frequency protocol (HFS) will be applied using the pulsed square waveform and 5 bursts of stimulation lasting 5 seconds at a frequency of 100 Hz separated by 55 s interval between bursts.

The low-frequency protocol (LFS) with stimulation at 2 Hz for 16 min with an intensity of 1000μA will subsequently be switched to.

The surgical intervention will be carried out by subarachnoid block with local anesthetic in accordance with the usual practice.

After its completion, a single injection block of the femoral nerve will be performed with a long-acting local anesthetic , a regional anesthesia technique included in routine clinical practice.
Device: Percutaneous neuromodulation using the EPTE® Bipolar System device

The two stimulation protocols will be applied consecutively. Firstly, the high-frequency protocol (HFS) will be applied in order to produce potentiation of the non-nociceptive pathway, using the pulsed square waveform and 5 bursts of stimulation lasting 5 seconds at a frequency of 100 Hz separated by 55 s interval between bursts. Adjustments to amplitude and pulse width are made until the patient experiences paresthesias at a perceptible but not painful intensity, and the intensity will be set 200 μA above the detection threshold for each subject.

In order to depress the nociceptive pathway, the low-frequency protocol (LFS) with stimulation at 2 Hz for 16 min with an intensity of 1000μA will subsequently be switched to. To ensure the recruitment of higher threshold type C nociceptive fibers, the intensity level will be programmed at the pain threshold for each subject.
No Intervention: Control group
The neuromodulation program will not be carried out. Only the maximum contraction force of the quadriceps prior to subarachnoid block will be measured. After the intervention, the femoral nerve block will be performed following the usual clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps maximal isometric contraction force differential after the use of a peripheral nerve neuromodulation program with direct current at low frequency combined with high frequency
Time Frame: Before neuromodulation, immediately after the first phase of the program, and 24 hours after it.
To compare (analyze) the differential of the maximum isometric contraction force of the quadriceps in the postoperative period after the use of a peripheral nerve neuromodulation program with direct current at low frequency combined with high frequency compared to the usual practice.
Before neuromodulation, immediately after the first phase of the program, and 24 hours after it.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score and Opioid use
Time Frame: In the immediate postoperative period in the PACU and at 24 hours
To compare the analgesic efficacy with the use of the described neuromodulation program versus the usual practice, in which it is not performed, in patients undergoing knee arthroplasty.
In the immediate postoperative period in the PACU and at 24 hours

Collaborators and Investigators

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

Sponsor

Hospital General Universitario de Valencia

Investigators

  • Study Director: JOSE DE ANDRES IBAÑEZ, FEA, Consorcio Hospital General de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20121994

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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