Shoulder SurgerySTIM-SHOULDERNCT07502170
Percutaneous Peripheral Nerve Stimulation (PPNS) for Post-Surgical Pain After Shoulder Surgery
A study testing Experimental: Neurostimulation Group in people with Shoulder Surgery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Despite the implementation of Enhanced Recovery After Surgery (ERAS) protocols incorporating multimodal analgesia and regional anesthesia, postoperative pain following shoulder surgery remains inadequately controlled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Surgery
- What is being tested?
- Experimental: Neurostimulation Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years old
- Patients scheduled for shoulder surgery under regional and general anesthesia
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xavier Capdevila contact
France1 site
CHU de Montpellier
Montpellier
Xavier CAPDEVILA, MD, +33467338256, x-capdevila@chu-montpellier.fr
Lucas DEFFONTIS, MD, l-deffontis@chu-montpellier.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Surgery
- Being tested
- Experimental: Neurostimulation Group, Control group
- Keywords
- neurostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Neurostimulation GroupDevice
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 groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurostimulation Group | Experimental | 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. Receives: Device: Experimental: Neurostimulation Group |
| Control Group | Active comparator | 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. Receives: Device: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative morphine consumption at 48 hours after surgery
The cumulative morphine sulfate consumption from the operating room discharge to 48 hours after surgery
Measured: From operating room discharge to 48 hours postoperatively
Secondary outcomes (8)
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
Measured: Before the surgery (day 0)
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
Measured: Before the surgery (day 0)
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
Measured: From admission to the Post-Anesthesia Care Unit (PACU) to 72 hours postoperatively
Diaphragmatic excursion assessed by ultrasound
Respiratory function assessment using diaphragmatic ultrasound to measure diaphragmatic excursion.
Measured: From operating room discharge to 24 hours postoperatively
Sniff nasal inspiratory pressure (SNIP)
Respiratory function assessment using sniff nasal inspiratory pressure measurement
Measured: From operating room discharge to 24 hours postoperatively
Maximal expiratory pressure (MEP)
Respiratory function assessment using maximal expiratory pressure measurement
Measured: From operating room discharge to 24 hours postoperatively
Total rescue analgesic consumption during at 72 hours after surgery
Cumulative morphine sulfate consumption during the first 72 hours postoperatively
Measured: From operating room discharge to 72 hours postoperatively
Functional recovery
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)
Measured: At 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502170
- Sponsor's protocol ID
- RECHMPL24_0044
- Other IDs
- 2024-A02821-46
- Acronym
- STIM-SHOULDER
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Peripheral Nerve Stimulation (PPNS), for Post-surgical Pain After Shoulder Surgery: a Prospective Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT07502170
- Acronym / sponsor ID
- STIM-SHOULDER / RECHMPL24_0044
- Conditions
- Shoulder Surgery
- Keywords
- neurostimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurostimulation Group | Experimental | Device: Experimental: Neurostimulation GroupThe 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 | Active comparator | Device: Control groupPatients in the control group will receive preoperative regional anesthesia to perform an interscalene block. In case of postoperative pain, patients will receive rescue analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged over 18 years old
- Patients scheduled for shoulder surgery under regional and general anesthesia
Key exclusion criteria (12 listed)
- Outpatient surgery
- Patients scheduled for magnetic resonance imaging (MRI)
- Patients with an implanted pacemaker
- Patients receiving chronic opioid therapy
- Opioid mesusage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Neurostimulation GroupThe 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 | Neurostimulation Group |
| Control groupActive 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. | Device | Control Group |
Primary outcome
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
8 secondary outcomes
Time required for catheter placement
Time frame: Before the surgery (day 0)
Pain intensity during regional anaesthesia placement
Time frame: Before the surgery (day 0)
Postoperative pain intensity
Time frame: 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
Sniff nasal inspiratory pressure (SNIP)
Time frame: From operating room discharge to 24 hours postoperatively
Maximal expiratory pressure (MEP)
Time frame: 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
Functional recovery
Time frame: At 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xavier Capdevila contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Neurostimulation Group in people with Shoulder Surgery, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Bringuier (+33467338661, s-bringuierbranchereau@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative morphine consumption at 48 hours after surgery (time frame: From operating room discharge to 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.