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

NCT05439213 | Completed

• 1 other identifier: 2021-A02773-38
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Rotator Cuff Tendinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

adrenaline 0,33 mg per litter

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

Group 2

EXPERIMENTAL

adrenaline 1 mg per litter

Drug: Adrenaline 1 Mg/mL Solution for Injection

Interventions

Adrenaline 0,33 Mg/mL Solution for Injection DRUG

adrenaline dosage

Group 1

Adrenaline 1 Mg/mL Solution for Injection DRUG

adrenaline dosage

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Clinique de l'Atlantique

Puilboreau, 17138, France

Location

MeSH Terms

Interventions

Injections; Epinephrine; Solutions

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 30, 2022
• Study Start: June 16, 2022
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)