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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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The purpose of this study is to to compare the post-anesthetic recovery time to awake consciousness and hemodynamic and ventilatory capacities for discharge from the Post-Interventional Monitoring Room in patients admitted for shoulder rotator cuff arthroscopy (using local anesthesia versus general anesthesia + local anesthesia).
This is a prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies used in outpatient, routine surgery.
The study population is composed of adult patients with complete or partial rotator cuff tears requiring reconstructive surgery under anesthesia at Hôpital Privé Clairval or Clinique Monticelli-Vélodrome.
Patients will be seen three times: at inclusion (during the preoperative consultation with the anesthetist), on the day of surgery (hospitalization), and at the follow-up visit (during the postoperative consultation with the surgeon). They will also be contacted by telephone on D1, D3 and D15 to optimize their follow-up. The duration of each patient's participation is approximately one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locoregional anesthesia | Experimental | patients will benefit from locoregional anesthesia alone by means of an interscalene block of the brachial plexus. |
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| Locoregional anesthesia + general anesthesia | Active Comparator | patients will benefit from general anesthesia as well as locoregional anesthesia via an interscalene block of the brachial plexus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arthroscopy of the shoulder rotator cuff | Procedure | minimally invasive surgical procedure in which a camera (arthroscope) is inserted into the shoulder joint |
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| Measure | Description | Time Frame |
|---|---|---|
| length of stay in the Post-Interventional Monitoring Room | The primary endpoint is the length of stay in the Post-Interventional Monitoring Room from discharge from the operating room to an Aldrete score > 8 leading to discharge from the Post-Interventional Monitoring Room. | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthieu CHIVOT, MD | Contact | 662347636 | +33 | chivot.matthieu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Clairval | Recruiting | Marseille | 13009 | France |
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Prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies
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open-label study
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