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

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Treatments: Epinephrine; Epinephryl borate; Pharmaceutical Solutions; Racepinephrine

Criteria

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