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

Not Applicable

Completed

• Conditions: Shoulder Rotator Cuff Tendinitis
• Interventions: Drug: Adrenaline 0,33 Mg/mL Solution for Injection; Drug: Adrenaline 1 Mg/mL Solution for Injection

• Registration Number: NCT05439213
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Timeline

• Study Start: 2022-06-16
• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Primary Completion: 2023-06-12
• Study Completion: 2023-06-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Adrenaline 0,33 Mg/mL Solution for Injection	adrenaline 0,33 mg per litter
Group 2	Adrenaline 1 Mg/mL Solution for Injection	adrenaline 1 mg per litter

Primary Outcome Measures

Name	Time	Method
Clarity of the arthroscopic surgical field	Day 1	The primary endpoint is the clarity of the arthroscopic surgical field assessed by the investigator at the end of the surgical procedure on a numerical scale of 0 to 10, where zero means total opacity throughout the procedure and ten means total clarity throughout the procedure.)

Secondary Outcome Measures

Name	Time	Method
Average blood pressure	Day 1	The mean intraoperative blood pressure is the average of all measurements taken during the procedure.
Average heart rate	Day 1	The mean intraoperative heart rate is the average of all measurements taken during the procedure.
Significant changes in blood pressure	Day 1	The analysis will compare the number of significant changes that occurred in each group and the number of patients per group with at least one significant change.
Significant changes in heart rate	Day 1	The analysis will compare the number of significant changes that occurred in each group and the number of patients per group with at least one significant change.
Evolution of the pressures of the arthropump	Day 1	The criteria considered in the analysis will be: the pressure set at the beginning of the procedure, the maximum pressure reached during the procedure and the number of transient hyperpressures requested during the procedure.
Duration of intervention	Day 1	The duration of the procedure is defined by the time between the beginning of the incision and the end of the suture.
Amount of saline used for the arthroscopic procedure (in litres)	Day 1	Amount of saline used for the arthroscopic procedure (in litres)

Trial Locations

Locations (1)

Clinique de l'Atlantique; 🇫🇷 Puilboreau, France