Local versus general plus local anesthesia for arthroscopic rotator cuff repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, open-label multicenter comparison of two anesthesia strategies for outpatient arthroscopic rotator cuff repair performed at Marseille centers. Adults with repairable partial or complete rotator cuff tears and ASA class I–III are randomized to receive either local/regional anesthesia alone or general anesthesia plus local/regional anesthesia. The primary outcomes are time to regain consciousness and hemodynamic and ventilatory stability required for discharge from the post-interventional monitoring room, with follow-up visits and phone calls on day 1, day 3 and day 15 and roughly one month of participation. Perioperative vitals, recovery milestones, and discharge readiness are recorded to compare safety and recovery profiles between the approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years;
* Patients with surgically repairable complete or partial rotator cuff tears;
* American Society of Anesthesiologists Class I to III;
* Patient able to understand study information;
* Patient willing to accept study evaluations and follow-up visits;
* Affiliation with a social insurance plan;
* Patient having been informed and having agreed to participate in the study by signing an informed consent form.

Exclusion Criteria:

* Contraindication to general or locoregional anesthesia;
* Chronic opioid use;
* Patient unable to understand study information (linguistic, psychological, cognitive, etc.);
* Patient unable to answer a self-questionnaire;
* Patient participating in or being excluded from another interventional research study;
* Pregnant or breast-feeding women;
* Protected patient (under legal protection, guardianship or deprived of liberty by judicial or administrative decision).

Where it's running

• Hôpital Privé Clairval
  Marseille, France Recruiting

Study contacts

• Study coordinator: Matthieu CHIVOT, MD
• Email: chivot.matthieu@gmail.com
• Phone: 662347636

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.