NCT05971095

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Hospital General Universitario de Valencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-01-01
• Completion: 2024-05-01
• First posted: 2023-08-02
• Last updated: 2023-08-02

Locations

1 site across 1 country: Spain