Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair (ALRAGA)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Not yet enrolling

Conditions: Rotator Cuff Syndrome

Treatments: Procedure: arthroscopy of the shoulder rotator cuff

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07093905

2025-A00971-48

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Locoregional anesthesia

Experimental group

Description:

patients will benefit from locoregional anesthesia alone by means of an interscalene block of the brachial plexus.

Treatment:

Procedure: arthroscopy of the shoulder rotator cuff

Locoregional anesthesia + general anesthesia

Active Comparator group

Description:

patients will benefit from general anesthesia as well as locoregional anesthesia via an interscalene block of the brachial plexus.

Treatment:

Procedure: arthroscopy of the shoulder rotator cuff