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

Hospital General Universitario de Valencia

Status: Enrolling

Conditions: Acute Pain

Treatments: Device: Percutaneous neuromodulation using the EPTE® Bipolar System device

Study type: Interventional

Funder types: Other

Identifiers

NCT05971095

20121994

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Neuromodulation group

Experimental group

Description:

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.

Treatment:

Device: Percutaneous neuromodulation using the EPTE® Bipolar System device

Control group

No Intervention group

Description:

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.