Skip to main content
OpenTrials
Completed

NCT Number: NCT05439213

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de l'Atlantique

Puilboreau, 17138, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adrenaline 0,33 Mg/mL Solution for Injection

Drug

adrenaline dosage

Adrenaline 1 Mg/mL Solution for Injection

Drug

adrenaline dosage

Primary outcomes

  1. Clarity of the arthroscopic surgical field

    Time frame: 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 outcomes

  1. Average blood pressure

    Time frame: Day 1

    The mean intraoperative blood pressure is the average of all measurements taken during the procedure.

  2. Average heart rate

    Time frame: Day 1

    The mean intraoperative heart rate is the average of all measurements taken during the procedure.

  3. Significant changes in blood pressure

    Time frame: 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.

  4. Significant changes in heart rate

    Time frame: 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.

  5. Evolution of the pressures of the arthropump

    Time frame: 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.

  6. Duration of intervention

    Time frame: Day 1

    The duration of the procedure is defined by the time between the beginning of the incision and the end of the suture.

  7. Amount of saline used for the arthroscopic procedure (in litres)

    Time frame: Day 1

    Amount of saline used for the arthroscopic procedure (in litres)

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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.

Acronym: PINHAR

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 30, 2022
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.