Comparison of the Effects of Two Concentrations of Adrenaline (0.33 mg/l vs 1 mg/l) in the Irrigation Serum of Arthroscopic Shoulder Surgery.

2021-A02773-38

The addition of adrenaline to the arthroscopic irrigation serum is used during rotator cuff surgery to limit intraoperative bleeding and ensure a clear view. Two concentrations of adrenaline are commonly used in practice: 1mg/L or 0.33 mg/L. The aim of this study is to determine which of these two doses provides better clarity of the surgical field with less impact on the patient's cardiovascular parameters.

2022-06-16

2023-06-12

2023-06-12

Completed

181

Inclusion Criteria: * Patient over 18 years of age, having read and signed the consent form for participation in the study after a reflection period (approximately 15 minutes) * Patient with a rotator cuff pathology (subacromial impingement, long biceps tendinopathy or rotator cuff tendinopathy) * Patient for whom an arthroscopic surgical indication has been given Exclusion Criteria: * Allergy to epinephrine * History of Takotsubo cardiomyopathy * Coagulation disorder * Patient under court protection, guardianship or curatorship * Patient not affiliated to the French social security system * Patient participating in another therapeutic protocol * Breastfeeding woman, * Pregnant woman or woman of childbearing age without highly effective contraception for the duration of the study (surgically sterile, intrauterine device (\> 14 days), hormonal contraception (same dose and formulation for at least 6 months), sexual abstinence. Women of childbearing age, i.e. fertile, are considered to be post-menopausal unless they are permanently infertile or have undergone surgical sterilisation. A post-menopausal condition is defined as the absence of menstruation for 12 months without any other medical cause * Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, double-blind, prospective, multicentre study in two parallel groups of 85 patients comparing two concentrations of adrenaline in arthroscopic irrigation fluid (0.33 mg/L vs 1 mg/L', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 181, 'type': 'ACTUAL'}}

2024-07-01