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)

  • STATUS
    Recruiting
  • days left to enroll
    2
  • participants needed
    170
  • sponsor
    GCS Ramsay Santé pour l'Enseignement et la Recherche
Updated on 11 July 2022

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.

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.

Details
Condition Shoulder Rotator Cuff Tendinitis
Treatment Adrenaline 1 Mg/mL Solution for Injection, Adrenaline 0,33 Mg/mL Solution for Injection
Clinical Study IdentifierNCT05439213
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche
Last Modified on11 July 2022

Eligibility

Yes No Not Sure

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
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