Actively Recruiting
Prospective, Randomized Study Comparing General Anesthesia Combined With Locoregional Anesthesia to Locoregional Anesthesia Alone for Arthroscopic Rotator Cuff Repair
Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2026-03-16
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead Sponsor
E
Euraxi Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two anesthesia methods for patients undergoing arthroscopic surgery to repair shoulder rotator cuff tears. This study evaluates whether using local anesthesia alone or combined with general anesthesia affects recovery time to awake consciousness and the ability to be discharged from the Post-Interventional Monitoring Room. The study is prospective, randomized, and conducted across multiple centers with adult patients needing reconstructive shoulder surgery. Participants will receive either locoregional anesthesia alone via an interscalene block of the brachial plexus or a combination of general anesthesia plus the same locoregional anesthesia. The surgical procedure involves minimally invasive arthroscopy of the shoulder rotator cuff. The study includes three visits: at enrollment during preoperative consultation, on the day of surgery, and at a postoperative follow-up with the surgeon. Telephone follow-ups occur on days 1, 3, and 15 after surgery. During the study, researchers will monitor the length of time patients stay in the Post-Interventional Monitoring Room on the day of surgery. Follow-up assessments include clinical evaluations and patient questionnaires conducted in person and by phone to optimize care. The total participation duration for each patient is approximately one month, allowing for thorough monitoring of recovery and safety.
CONDITIONS
Brief Title
Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients with surgically repairable complete or partial rotator cuff tears
- American Society of Anesthesiologists Class I to III
- Ability to understand study information
- Willingness to accept study evaluations and follow-up visits
- Affiliation with a social insurance plan
- Signed informed consent to participate in the study
You will not qualify if you...
- Contraindication to general or locoregional anesthesia
- Chronic opioid use
- Inability to understand study information (linguistic, psychological, cognitive, etc.)
- Inability to answer a self-questionnaire
- Current participation or exclusion from another interventional research study
- Pregnant or breastfeeding women
- Protected patient status (under legal protection, guardianship, or deprived of liberty by judicial or administrative decision)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during the preoperative consultation with the anesthetist
Duration - 1 day
Participants undergo arthroscopic rotator cuff repair surgery under locoregional anesthesia alone or combined with general anesthesia, followed by monitoring in the post-interventional room.
1 visit (hospitalization day of surgery)
Duration - Approximately 1 month
Participants attend a follow-up visit with the surgeon and receive telephone contacts to optimize recovery and monitor progress after surgery.
1 in-person follow-up visit and 3 telephone contacts on Days 1, 3, and 15 post-surgery
Trial Site Locations
Total: 1 location
1
Hôpital Privé Clairval
Marseille, France, 13009
Actively Recruiting
Research Team
M
Matthieu CHIVOT, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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