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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02821-46 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Neurostimulation Group | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Bringuier | Contact | +33467338661 | s-bringuierbranchereau@chu-montpellier.fr | |
| Xavier Capdevila | Contact | x-capdevila@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Montpellier | France |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Device | 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. |
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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 |
| D008722 | Methods |