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

March 30, 2026 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurostimulation Group
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.
Device: Experimental: Neurostimulation Group
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.
Active Comparator: Control Group
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.
Device: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From operating room discharge to 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before the surgery (day 0)
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
Before the surgery (day 0)
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
From admission to the Post-Anesthesia Care Unit (PACU) to 72 hours postoperatively
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.
From operating room discharge to 24 hours postoperatively
Sniff nasal inspiratory pressure (SNIP)
Time Frame: From operating room discharge to 24 hours postoperatively
Respiratory function assessment using sniff nasal inspiratory pressure measurement
From operating room discharge to 24 hours postoperatively
Maximal expiratory pressure (MEP)
Time Frame: From operating room discharge to 24 hours postoperatively
Respiratory function assessment using maximal expiratory pressure measurement
From operating room discharge to 24 hours postoperatively
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
From operating room discharge to 72 hours postoperatively
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)
At 72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL24_0044
  • 2024-A02821-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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