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)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Puilboreau, France, 17138
    • Clinique de l'Atlantique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; adrenaline 0,33 mg per litter	Drug: Adrenaline 0,33 Mg/mL Solution for Injection; adrenaline dosage
Experimental: Group 2; adrenaline 1 mg per litter	Drug: Adrenaline 1 Mg/mL Solution for Injection; adrenaline dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clarity of the arthroscopic surgical field	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.)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average blood pressure	The mean intraoperative blood pressure is the average of all measurements taken during the procedure.	Day 1
Average heart rate	The mean intraoperative heart rate is the average of all measurements taken during the procedure.	Day 1
Significant changes in blood pressure	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.	Day 1
Significant changes in heart rate	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.	Day 1
Evolution of the pressures of the arthropump	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.	Day 1
Duration of intervention	The duration of the procedure is defined by the time between the beginning of the incision and the end of the suture.	Day 1
Amount of saline used for the arthroscopic procedure (in litres)	Amount of saline used for the arthroscopic procedure (in litres)	Day 1

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 12, 2023

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Pharmaceutical Solutions; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 2021-A02773-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No