Shoulder Surgery
Conditions
Keywords
neurostimulation
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 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
DEVICEExperimental: 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.
DEVICEControl 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.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative morphine consumption at 48 hours after surgery | From operating room discharge to 48 hours postoperatively | The cumulative morphine sulfate consumption from the operating room discharge to 48 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time required for catheter placement | 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 |
| Pain intensity during regional anaesthesia placement | 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 |
| Postoperative pain intensity | 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 |
| Diaphragmatic excursion assessed by ultrasound | From operating room discharge to 24 hours postoperatively | Respiratory function assessment using diaphragmatic ultrasound to measure diaphragmatic excursion. |
| Sniff nasal inspiratory pressure (SNIP) | From operating room discharge to 24 hours postoperatively | Respiratory function assessment using sniff nasal inspiratory pressure measurement |
| Maximal expiratory pressure (MEP) | From operating room discharge to 24 hours postoperatively | Respiratory function assessment using maximal expiratory pressure measurement |
| Total rescue analgesic consumption during at 72 hours after surgery | From operating room discharge to 72 hours postoperatively | Cumulative morphine sulfate consumption during the first 72 hours postoperatively |
| Functional recovery | 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) |
Countries
France
Contacts
CONTACTSophie Bringuier
CONTACTXavier Capdevila
Outcome results
None listed