Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair

NCT07093905 | Recruiting

• 1 other identifier: 2025-A00971-48
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Rotator Cuff Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Locoregional anesthesia

EXPERIMENTAL

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

Procedure: arthroscopy of the shoulder rotator cuff

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.

Procedure: arthroscopy of the shoulder rotator cuff

Interventions

arthroscopy of the shoulder rotator cuff PROCEDURE

minimally invasive surgical procedure in which a camera (arthroscope) is inserted into the shoulder joint

Locoregional anesthesia; Locoregional anesthesia + general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé Clairval

Marseille, 13009, France

RECRUITING

Central Study Contacts

Matthieu CHIVOT, MD

CONTACT

662347636; chivot.matthieu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open-label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: March 12, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

FR (1)