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

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.

Sponsors

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

Source GCS Ramsay Santé pour l'Enseignement et la Recherche
Brief 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.

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.

Overall Status Recruiting
Start Date 2022-06-22
Completion Date 2022-11-30
Primary Completion Date 2022-11-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Clarity of the arthroscopic surgical field Day 1
Secondary Outcome
Measure Time Frame
Average blood pressure Day 1
Average heart rate Day 1
Significant changes in blood pressure Day 1
Significant changes in heart rate Day 1
Evolution of the pressures of the arthropump Day 1
Duration of intervention Day 1
Amount of saline used for the arthroscopic procedure (in litres) Day 1
Enrollment 170
Condition
Intervention

Intervention Type: Drug

Intervention Name: Adrenaline 0,33 Mg/mL Solution for Injection

Description: adrenaline dosage

Arm Group Label: Group 1

Intervention Type: Drug

Intervention Name: Adrenaline 1 Mg/mL Solution for Injection

Description: adrenaline dosage

Arm Group Label: Group 2

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Edouard HARLY, MD

Phone: 05 36 28 85 00

Phone Ext.: 33

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Clinique de l'Atlantique Edouard HARLY, MD Edouard HARLY, MD Principal Investigator
Location Countries

France

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group 1

Type: Experimental

Description: adrenaline 0,33 mg per litter

Label: Group 2

Type: Experimental

Description: adrenaline 1 mg per litter

Acronym PINHAR
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomised, double-blind, prospective, multicentre study in two parallel groups of 85 patients comparing two concentrations of adrenaline in arthroscopic irrigation fluid (0.33 mg/L vs 1 mg/L

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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