Local versus general plus local anesthesia for arthroscopic rotator cuff repair

Prospective, Randomized Study Comparing General Anesthesia Combined With Locoregional Anesthesia to Locoregional Anesthesia Alone for Arthroscopic Rotator Cuff Repair.

This trial tests whether local/regional anesthesia alone or general anesthesia plus local/regional anesthesia helps adults recover consciousness and stable breathing/heart function faster after arthroscopic rotator cuff repair.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche (Academic / other)
• Locations: 1 site (Marseille)
• Trial ID: NCT07093905 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with surgically repairable partial or complete rotator cuff tears, ASA class I–III, who can understand the study and attend preoperative and postoperative visits are ideal candidates.

Not a fit: Patients with contraindications to general or regional anesthesia, chronic opioid use, pregnancy or breastfeeding, inability to complete questionnaires, or under legal protection are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, one anesthesia approach could let patients wake up and meet discharge criteria sooner, shortening recovery time after outpatient rotator cuff surgery.

How similar studies have performed: Previous studies comparing regional/local versus general anesthesia for shoulder procedures have often shown faster recovery and lower opioid needs, but results vary and direct comparisons specifically for outpatient rotator cuff repair remain limited.

Eligibility criteria

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 this trial is running

Marseille

• Hôpital Privé Clairval — Marseille, France (Recruiting)

Study contacts

• Study coordinator: Matthieu CHIVOT, MD

Conditions Rotator Cuff Syndrome