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NCT Number: NCT07093905

Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Clairval

Marseille, 13009, France

Location status: Recruiting

Location contact

Matthieu CHIVOT

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

arthroscopy of the shoulder rotator cuff

Procedure

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

Primary outcomes

  1. length of stay in the Post-Interventional Monitoring Room

    Time frame: Day 0

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthieu CHIVOT, MD

CONTACT

[email protected]

662347636 ext. +33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study title

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

Acronym: ALRAGA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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