Clinical trial NCT05439213: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Rotator Cuff Tendinitis
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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 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.

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 mg/L):

Maximum duration of patient participation in the study = 1 day.

Eligibility 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

Primary outcomes:
measure: Clarity of the arthroscopic surgical field
timeFrame: Day 1
Secondary outcomes:
measure: Average blood pressure
timeFrame: Day 1
measure: Average heart rate
timeFrame: Day 1
measure: Significant changes in blood pressure
timeFrame: Day 1
measure: Significant changes in heart rate
timeFrame: Day 1
measure: Evolution of the pressures of the arthropump
timeFrame: Day 1
measure: Duration of intervention
timeFrame: Day 1
measure: Amount of saline used for the arthroscopic procedure (in litres)
timeFrame: Day 1
Other outcomes:
Locations:
city: Puilboreau
country: France
facility: Clinique de l'Atlantique
Study officials:
References: