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Percutaneous Peripheral Nerve Stimulation (PPNS) for Post-Surgical Pain After Shoulder Surgery

ConditionShoulder Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

Despite the implementation of Enhanced Recovery After Surgery (ERAS) protocols incorporating multimodal analgesia and regional anesthesia, postoperative pain following shoulder surgery remains inadequately controlled. Percutaneous peripheral nerve stimulation (PPNS) represents a potential alternative strategy for postoperative pain management. This prospective randomized study aims to assess the efficacy of PPNS for postoperative pain control following shoulder surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged over 18 years old

Patients scheduled for shoulder surgery under regional and general anesthesia

Disqualifiers

Outpatient surgery

Patients scheduled for magnetic resonance imaging (MRI)

Patients with an implanted pacemaker

Patients receiving chronic opioid therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental: Neurostimulation Group

    Device

    The catheter will be placed preoperatively and used to perform the interscalene block. Postoperative peripheral nerve stimulation therapy will be initiated in case of pain. Stimulation sessions of approximately 20 minutes will be delivered, with parameters adjusted according to the patient's perception within a patient-centered neuromodulation approach. Stimulation settings may be modified by the physician (20-100 Hz, pulse width 0.1 ms, intensity 0.1-0.5 mA), with a maximum of three sessions per day. If this strategy fails to provide adequate analgesia, rescue analgesia will be administered.

  • Control group

    Device

    Active Comparator: Control Group Arm Description: Patients in the control group will receive preoperative regional anesthesia to perform an interscalene block. In case of postoperative pain, patients will receive rescue analgesia.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Neurostimulation GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative morphine consumption at 48 hours after surgery

The cumulative morphine sulfate consumption from the operating room discharge to 48 hours after surgery

Time frame
From operating room discharge to 48 hours postoperatively

Secondary outcomes

1

Time required for catheter placement

Time required for peripheral nerve stimulation catheter placement, defined as the interval from initiation of sterile preparation to completion of catheter securement

Time frame
Before the surgery (day 0)
2

Pain intensity during regional anaesthesia placement

Pain intensity during regional anaesthesia placement assessed using a 0-10 Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates worst imaginable pain

Time frame
Before the surgery (day 0)
3

Postoperative pain intensity

Patient-reported postoperative pain intensity assessed using a 0-10 Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates worst imaginable pain

Time frame
From admission to the Post-Anesthesia Care Unit (PACU) to 72 hours postoperatively
4

Diaphragmatic excursion assessed by ultrasound

Respiratory function assessment using diaphragmatic ultrasound to measure diaphragmatic excursion.

Time frame
From operating room discharge to 24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: