Comparison Between Percutaneous Femoral Nerve Neuromodulation Associated With Femoral Nerve Block and Standard Clinical Practice in Patients Undergoing Knee Arthroplasty. (NEPFAR)
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| ClinicalTrials.gov Identifier: NCT05971095 |
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Recruitment Status :
Recruiting
First Posted : August 2, 2023
Last Update Posted : August 2, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Pain | Device: Percutaneous neuromodulation using the EPTE® Bipolar System device | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Percutaneous Femoral Nerve Neuromodulation for Postoperative Analgesia and Functional Recovery Following Knee Arthroplasty. |
| Actual Study Start Date : | June 1, 2023 |
| Estimated Primary Completion Date : | January 1, 2024 |
| Estimated Study Completion Date : | May 1, 2024 |
| Arm | Intervention/treatment |
|---|---|
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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. |
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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.
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- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05971095
| Contact: FERRAN MARQUES PEIRO, MD | 34671364792 | fermarpei@gmail.com | |
| Contact: CARLOS DELGADO NAVARRO, FEA | 34622523552 | cardelna@gmail.com |
| Spain | |
| Hospital General Universitario de Valencia | Recruiting |
| Valencia, Spain, 46020 | |
| Contact: Ferran Marques Peiro 671364792 fermarpei@gmail.com | |
| Study Director: | JOSE DE ANDRES IBAÑEZ, FEA | CONSORCIO HOSPITAL GENERAL DE VALENCIA |
Other Publications:
| Responsible Party: | FERRAN MARQUES PEIRO, Principal Investigator, Hospital General Universitario de Valencia |
| ClinicalTrials.gov Identifier: | NCT05971095 |
| Other Study ID Numbers: |
20121994 |
| First Posted: | August 2, 2023 Key Record Dates |
| Last Update Posted: | August 2, 2023 |
| Last Verified: | July 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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 |
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PENS Neuromodulation Percutaneous peripheral nere stimulation |
Postoperative pain Acute pain after surgery Total Knee arthtolasty |
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Acute Pain Pain Neurologic Manifestations |