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)
Primary Purpose
Shoulder Rotator Cuff Tendinitis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adrenaline 0,33 Mg/mL Solution for Injection
Adrenaline 1 Mg/mL Solution for Injection
Sponsored by
About this trial
This is an interventional prevention trial for Shoulder Rotator Cuff Tendinitis
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
Sites / Locations
- Clinique de l'AtlantiqueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
adrenaline 0,33 mg per litter
adrenaline 1 mg per litter
Outcomes
Primary Outcome Measures
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.)
Secondary Outcome Measures
Average blood pressure
The mean intraoperative blood pressure is the average of all measurements taken during the procedure.
Average heart rate
The mean intraoperative heart rate is the average of all measurements taken during the procedure.
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.
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.
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.
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.
Amount of saline used for the arthroscopic procedure (in litres)
Amount of saline used for the arthroscopic procedure (in litres)
Full Information
NCT ID
NCT05439213
First Posted
June 22, 2022
Last Updated
June 27, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05439213
Brief 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
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Rotator Cuff Tendinitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
adrenaline 0,33 mg per litter
Arm Title
Group 2
Arm Type
Experimental
Arm Description
adrenaline 1 mg per litter
Intervention Type
Drug
Intervention Name(s)
Adrenaline 0,33 Mg/mL Solution for Injection
Intervention Description
adrenaline dosage
Intervention Type
Drug
Intervention Name(s)
Adrenaline 1 Mg/mL Solution for Injection
Intervention Description
adrenaline dosage
Primary Outcome Measure Information:
Title
Clarity of the arthroscopic surgical field
Description
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.)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Average blood pressure
Description
The mean intraoperative blood pressure is the average of all measurements taken during the procedure.
Time Frame
Day 1
Title
Average heart rate
Description
The mean intraoperative heart rate is the average of all measurements taken during the procedure.
Time Frame
Day 1
Title
Significant changes in blood pressure
Description
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.
Time Frame
Day 1
Title
Significant changes in heart rate
Description
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.
Time Frame
Day 1
Title
Evolution of the pressures of the arthropump
Description
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.
Time Frame
Day 1
Title
Duration of intervention
Description
The duration of the procedure is defined by the time between the beginning of the incision and the end of the suture.
Time Frame
Day 1
Title
Amount of saline used for the arthroscopic procedure (in litres)
Description
Amount of saline used for the arthroscopic procedure (in litres)
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edouard HARLY, MD
Phone
05 36 28 85 00
Ext
33
Email
dr.edouard.harly@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony PINCIN
Email
antony.pincin@orange.fr
Facility Information:
Facility Name
Clinique de l'Atlantique
City
Puilboreau
ZIP/Postal Code
17138
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard HARLY, MD
First Name & Middle Initial & Last Name & Degree
Edouard HARLY, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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