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)

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Enrolling

Conditions

Shoulder Rotator Cuff Tendinitis

Treatments

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

170 estimated 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

170 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

Trial contacts and locations

1

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Central trial contact

Anthony PINCIN; Edouard HARLY, MD

Data sourced from clinicaltrials.gov

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