Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07093905

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

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

Surgery and Immediate Post-operative Care

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)

Post-operative Follow-up

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

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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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