Status:
COMPLETED
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
Conditions:
Shoulder Rotator Cuff Tendinitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 commo...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2023
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT05439213
Start Date
June 16 2022
End Date
June 12 2023
Last Update
July 1 2024
Active Locations (1)
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1
Clinique de l'Atlantique
Puilboreau, France, 17138