Comparison Between Percutaneous Femoral Nerve Neuromodulation Associated With Femoral Nerve Block and Standard Clinical Practice in Patients Undergoing Knee Arthroplasty.
- Conditions
- Acute Pain
- Interventions
- Device: Percutaneous neuromodulation using the EPTE® Bipolar System device
- Registration Number
- NCT05971095
- Lead Sponsor
- Hospital General Universitario de Valencia
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- Over 18 years
- Those who sign the informed consent
- Not pregnant
- Cognitive capacity that allows subjective postoperative evaluations.
- Under 18 years old
- IC rejection or withdrawal
- Pregnancy
- Cognitive impairment
- Contraindication for Regional Anesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neuromodulation group Percutaneous neuromodulation using the EPTE® Bipolar System device 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.
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method VAS score and Opioid use 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.
Trial Locations
- Locations (1)
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain