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

Last updated: June 28, 2024
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Overall Status: Completed

Phase

N/A

Condition

Tendon Injuries

Sprains

Treatment

Adrenaline 1 Mg/mL Solution for Injection

Adrenaline 0,33 Mg/mL Solution for Injection

Clinical Study ID

NCT05439213
2021-A02773-38
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient over 18 years of age, having read and signed the consent form forparticipation in the study after a reflection period (approximately 15 minutes)

  • Patient with a rotator cuff pathology (subacromial impingement, long bicepstendinopathy or rotator cuff tendinopathy)

  • Patient for whom an arthroscopic surgical indication has been given

Exclusion

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 contraceptionfor the duration of the study (surgically sterile, intrauterine device (> 14 days),hormonal contraception (same dose and formulation for at least 6 months), sexualabstinence. Women of childbearing age, i.e. fertile, are considered to bepost-menopausal unless they are permanently infertile or have undergone surgicalsterilisation. A post-menopausal condition is defined as the absence of menstruationfor 12 months without any other medical cause

  • Patient unable to understand informed information and/or give written informedconsent: dementia, psychosis, disturbed consciousness, non-French speaking patient

Study Design

Total Participants: 181
Treatment Group(s): 2
Primary Treatment: Adrenaline 1 Mg/mL Solution for Injection
Phase:
Study Start date:
June 16, 2022
Estimated Completion Date:
June 12, 2023

Study 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.

Connect with a study center

  • Clinique de l'Atlantique

    Puilboreau, 17138
    France

    Site Not Available

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