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 (PINHAR)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Completed

Conditions: Shoulder Rotator Cuff Tendinitis

Treatments: Drug: Adrenaline 1 Mg/mL Solution for Injection; Drug: Adrenaline 0,33 Mg/mL Solution for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05439213

2021-A02773-38

Details and patient eligibility

About

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.

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

181 participants in 2 patient groups

Group 1

Experimental group

Description:

adrenaline 0,33 mg per litter

Treatment:

Drug: Adrenaline 0,33 Mg/mL Solution for Injection

Group 2

Experimental group

Description:

adrenaline 1 mg per litter

Treatment:

Drug: Adrenaline 1 Mg/mL Solution for Injection