Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: arthroscopy of the shoulder rotator cuff.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Randomized Study Comparing General Anesthesia Combined With Locoregional Anesthesia to Locoregional Anesthesia Alone for Arthroscopic Rotator Cuff Repair.
Overview
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.
Interventions
- Procedure arthroscopy of the shoulder rotator cuff
minimally invasive surgical procedure in which a camera (arthroscope) is inserted into the shoulder joint
Primary outcome measures
- length of stay in the Post-Interventional Monitoring Room [Time frame: Day 0]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hôpital Privé Clairval — Marseille
Identifiers
NCT: NCT07093905 · 2025-A00971-48