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NCT Number: NCT07502170

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

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.

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Key information

Conditions

Shoulder Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

All patients will receive multimodal analgesia including preoperative regional anesthesia with an ultrasound-guided interscalene block. Patients randomized to the experimental group will receive a perineural catheter allowing postoperative peripheral nerve stimulation.The aim of this study is to evaluate whether percutaneous peripheral nerve stimulation using stimulating catheters can reduce postoperative pain intensity while preserving respiratory function in patients undergoing shoulder surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged over 18 years old
  • Patients scheduled for shoulder surgery under regional and general anesthesia

Exclusion criteria

  • Outpatient surgery
  • Patients scheduled for magnetic resonance imaging (MRI)
  • Patients with an implanted pacemaker
  • Patients receiving chronic opioid therapy
  • Opioid mesusage
  • Contraindication to general anesthesia
  • Contraindication to regional anesthesia
  • Contraindication to analgesics (morphine sulfate, nonsteroidal anti-inflammatory drugs or acetaminophen)
  • Any contraindication listed in the instructions for use of the investigational medical device
  • Inability to complete a self-assessment questionnaire
  • Inability to ensure follow-up for 72 hours postoperatively
  • Lack of written informed consent

Treatment and study plan

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.

Primary outcomes

  1. Cumulative morphine consumption at 48 hours after surgery

    Time frame: From operating room discharge to 48 hours postoperatively

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

Secondary outcomes

  1. Time required for catheter placement

    Time frame: Before the surgery (day 0)

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

  2. Pain intensity during regional anaesthesia placement

    Time frame: Before the surgery (day 0)

    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

  3. Postoperative pain intensity

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

    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

  4. Diaphragmatic excursion assessed by ultrasound

    Time frame: From operating room discharge to 24 hours postoperatively

    Respiratory function assessment using diaphragmatic ultrasound to measure diaphragmatic excursion.

  5. Sniff nasal inspiratory pressure (SNIP)

    Time frame: From operating room discharge to 24 hours postoperatively

    Respiratory function assessment using sniff nasal inspiratory pressure measurement

  6. Maximal expiratory pressure (MEP)

    Time frame: From operating room discharge to 24 hours postoperatively

    Respiratory function assessment using maximal expiratory pressure measurement

  7. Total rescue analgesic consumption during at 72 hours after surgery

    Time frame: From operating room discharge to 72 hours postoperatively

    Cumulative morphine sulfate consumption during the first 72 hours postoperatively

  8. Functional recovery

    Time frame: At 72 hours postoperatively

    Functional recovery at 72 hours postoperatively assessed using the Questionnaire of Recovery-15 (QoR-15). The overall score ranges from 0 (worst recovery) to 150 (best recovery)

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie Bringuier

CONTACT

[email protected]

+33467338661

Xavier Capdevila

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Percutaneous Peripheral Nerve Stimulation (PPNS), for Post-surgical Pain After Shoulder Surgery: a Prospective Comparative Randomized Study

Acronym: STIM-SHOULDER

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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