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Clinical Trial NCT07502170 (STIM-SHOULDER) for Shoulder Surgery is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Percutaneous Peripheral Nerve Stimulation (PPNS) for Post-Surgical Pain After Shoulder Surgery (STIM-SHOULDER) 60 Randomized
Clinical Trial NCT07502170 (STIM-SHOULDER) is an interventional study for Shoulder Surgery and is currently not yet recruiting. Enrollment is planned to begin on April 1, 2026 and continue until the study accrues 60 participants. Led by University Hospital, Montpellier, this study is expected to complete by September 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief 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. 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 ...Show More
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 intens...Show More
Official Title
Percutaneous Peripheral Nerve Stimulation (PPNS), for Post-surgical Pain After Shoulder Surgery: a Prospective Comparative Randomized Study
Conditions
Shoulder SurgeryOther Study IDs
- STIM-SHOULDER
- RECHMPL24_0044
- 2024-A02821-46 (Other Identifier) (ANSM)
NCT ID Number
Start Date (Actual)
2026-04
Last Update Posted
2026-03-30
Completion Date (Estimated)
2028-09
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
neurostimulation
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalNeurostimulation 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...Show More | 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...Show More |
Active ComparatorControl 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. | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cumulative morphine consumption at 48 hours after surgery | The cumulative morphine sulfate consumption from the operating room discharge to 48 hours after surgery | From operating room discharge to 48 hours postoperatively |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 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 | 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 | 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. | From operating room discharge to 24 hours postoperatively |
Sniff nasal inspiratory pressure (SNIP) | Respiratory function assessment using sniff nasal inspiratory pressure measurement | From operating room discharge to 24 hours postoperatively |
Maximal expiratory pressure (MEP) | 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 | Cumulative morphine sulfate consumption during the first 72 hours postoperatively | 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) | At 72 hours postoperatively |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Patients aged over 18 years old
- Patients scheduled for shoulder surgery under regional and general anesthesia
- 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
University Hospital, MontpellierStudy Central Contact
Contact: Sophie Bringuier, +33467338661, [email protected]
Contact: Xavier Capdevila, [email protected]
No location data.