Acute Pain
Conditions
Keywords
PENS, Neuromodulation, Percutaneous peripheral nere stimulation, Postoperative pain, Acute pain after surgery, Total Knee arthtolasty
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.
Interventions
DEVICEPercutaneous 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.
Sponsors
Hospital General Universitario de Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Contacts
Primary ContactFERRAN MARQUES PEIRO, MD
Backup ContactCARLOS DELGADO NAVARRO, FEA
Outcome results
None listed