Clinical trial NCT05971095: Comparison Between Percutaneous Femoral Nerve Neuromodulation Associated With Femoral Nerve Block and Standard Clinical Practice in Patients Undergoing Knee Arthroplasty.
Official title: Percutaneous Femoral Nerve Neuromodulation for Postoperative Analgesia and Functional Recovery Following Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pain
Keywords: PENS
Neuromodulation
Percutaneous peripheral nere stimulation
Postoperative pain
Acute pain after surgery
Total Knee arthtolasty
Lead sponsor: Hospital General Universitario de Valencia
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an analytical study (with hypothesis testing) of a single-center, unblinded, randomized clinical trial. The patients will be separated between the intervention group and the control group.

To carry out the assignment of interventions, a methodology by blocks of 2 without stratification will be used. To obtain the sequence of random numbers, the official Clinical Trial Randomization Tool of the National Cancer Institute (USA) will be used.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Before neuromodulation, immediately after the first phase of the program, and 24 hours after it.
Secondary outcomes:
measure: VAS score and Opioid use
timeFrame: In the immediate postoperative period in the PACU and at 24 hours
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
affiliation: CONSORCIO HOSPITAL GENERAL DE VALENCIA
name: JOSE DE ANDRES IBAÑEZ, FEA
role: STUDY_DIRECTOR
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