Percutaneous Peripheral Nerve Stimulation (PPNS) for Post-Surgical Pain After Shoulder Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: Neurostimulation Group, Control group.
- Who it may be relevant to
- Registry conditions: Shoulder Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Percutaneous Peripheral Nerve Stimulation (PPNS), for Post-surgical Pain After Shoulder Surgery: a Prospective Comparative Randomized Study
Overview
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.
Interventions
- 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 pe - 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.
Primary outcome measures
- Cumulative morphine consumption at 48 hours after surgery [Time frame: From operating room discharge to 48 hours postoperatively]
Secondary outcome measures (8)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Montpellier — Montpellier
Identifiers
NCT: NCT07502170 · RECHMPL24_0044 · 2024-A02821-46