NEPFAR: Comparison Between Percutaneous Femoral Nerve Neuromodulation Associated With Femoral Nerve Block and Standard Clinical Practice in Patients Undergoing Knee Arthroplasty.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Over 18 years
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Those who sign the informed consent
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Not pregnant
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Cognitive capacity that allows subjective postoperative evaluations.
Exclusion Criteria:
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Under 18 years old
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IC rejection or withdrawal
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Pregnancy
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Cognitive impairment
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Contraindication for Regional Anesthesia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital General Universitario de Valencia | Valencia | Spain | 46020 |
Sponsors and Collaborators
- Hospital General Universitario de Valencia
Investigators
- Study Director: JOSE DE ANDRES IBAÑEZ, FEA, CONSORCIO HOSPITAL GENERAL DE VALENCIA
Study Documents (Full-Text)
None provided.More Information
Publications
- Dos'Santos T, Thomas C, Comfort P, McMahon JJ, Jones PA. Relationships between Isometric Force-Time Characteristics and Dynamic Performance. Sports (Basel). 2017 Sep 13;5(3):68. doi: 10.3390/sports5030068.
- Maffiuletti NA. Assessment of hip and knee muscle function in orthopaedic practice and research. J Bone Joint Surg Am. 2010 Jan;92(1):220-9. doi: 10.2106/JBJS.I.00305.
- Rice DA, McNair PJ. Quadriceps arthrogenic muscle inhibition: neural mechanisms and treatment perspectives. Semin Arthritis Rheum. 2010 Dec;40(3):250-66. doi: 10.1016/j.semarthrit.2009.10.001. Epub 2009 Dec 2.
- Ripolles-Melchor J, Abad-Motos A, Diez-Remesal Y, Aseguinolaza-Pagola M, Padin-Barreiro L, Sanchez-Martin R, Logrono-Egea M, Catala-Bauset JC, Garcia-Orallo S, Bisbe E, Martin N, Suarez-de-la-Rica A, Cuellar-Martinez AB, Gil-Trujillo S, Estupinan-Jimenez JC, Villanova-Baraza M, Gil-Lapetra C, Perez-Sanchez P, Rodriguez-Garcia N, Ramiro-Ruiz A, Farre-Tebar C, Martinez-Garcia A, Arauzo-Perez P, Garcia-Perez C, Abad-Gurumeta A, Minambres-Villar MA, Sanchez-Campos A, Jimenez-Lopez I, Tena-Guerrero JM, Marin-Pena O, Sanchez-Merchante M, Vicente-Gutierrez U, Cassinello-Ogea MC, Ferrando-Ortola C, Berges-Gutierrez H, Fernanz-Anton J, Gomez-Rios MA, Bordonaba-Bosque D, Ramirez-Rodriguez JM, Garcia-Erce JA, Aldecoa C; Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol in Elective Total Hip and Knee Arthroplasty (POWER2) Study Investigators Group for the Spanish Perioperative Audit and Research Network (REDGERM). Association Between Use of Enhanced Recovery After Surgery Protocol and Postoperative Complications in Total Hip and Knee Arthroplasty in the Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol in Elective Total Hip and Knee Arthroplasty Study (POWER2). JAMA Surg. 2020 Apr 1;155(4):e196024. doi: 10.1001/jamasurg.2019.6024. Epub 2020 Apr 15.
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