Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair

NCT ID: NCT07093905

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

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).

Detailed 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.

Conditions

Rotator Cuff Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Locoregional anesthesia

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

Group Type: EXPERIMENTAL

arthroscopy of the shoulder rotator cuff

Intervention Type: PROCEDURE

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

Locoregional anesthesia + general anesthesia

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

Group Type: ACTIVE_COMPARATOR

arthroscopy of the shoulder rotator cuff

Intervention Type: PROCEDURE

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

Interventions

arthroscopy of the shoulder rotator cuff

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

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Privé Clairval

Marseille, , France

Countries

France

Central Contacts

Matthieu CHIVOT, MD

Role: CONTACT

chivot.matthieu@gmail.com

662347636 ext. +33

Facility Contacts

Matthieu CHIVOT

Role: primary

chivot.matthieu@gmail.com

Other Identifiers

2025-A00971-48

Identifier Type: -

Identifier Source: org_study_id