Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair

GCS Ramsay Santé pour l'Enseignement et la Recherche34 enrolled

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rotator Cuff Syndrome

Interventions

arthroscopy of the shoulder rotator cuffPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Hôpital Privé Clairval

Marseille, France

RECRUITING

Outcomes

Primary Outcomes

length of stay in the Post-Interventional Monitoring Room

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.

Time frame: Day 0

Central Contacts

Matthieu CHIVOT, MD

CONTACT

662347636 chivot.matthieu@gmail.com

Data from ClinicalTrials.gov

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