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

Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

A prospective, randomised, double-blind, multicentre study in two parallel groups of 85 patients comparing two concentrations of adrenaline in the irrigation fluid of an arthroscopy (0.33 mg/L vs. 1 mg/L): Maximum duration of patient participation in the study = 1 day.

• Shoulder Rotator Cuff Tendinitis

Intervention Type: Drug

Intervention Name: Adrenaline 0,33 Mg/mL Solution for Injection

Description: adrenaline dosage

Arm Group Label: Group 1

Intervention Type: Drug

Intervention Name: Adrenaline 1 Mg/mL Solution for Injection

Description: adrenaline dosage

Arm Group Label: Group 2

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Last Name: Edouard HARLY, MD

Phone: 05 36 28 85 00

Phone Ext.: 33

Email: [email protected]

France

2022-06-01

Type: Sponsor

• Tendinopathy
• Rotator Cuff Injuries

Label: Group 1

Type: Experimental

Description: adrenaline 0,33 mg per litter

Label: Group 2

Type: Experimental

Description: adrenaline 1 mg per litter

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 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

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)