Shoulder Rotator Cuff TendinitisPINHARNCT05439213
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
A study testing Adrenaline 0,33 Mg/mL Solution for Injection and Adrenaline 1 Mg/mL Solution for Injection in people with Shoulder Rotator Cuff Tendinitis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Rotator Cuff Tendinitis
- What is being tested?
- Adrenaline 0,33 Mg/mL Solution for Injection and Adrenaline 1 Mg/mL Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2022to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Shoulder Rotator Cuff Tendinitis
- Being tested
- Adrenaline 0,33 Mg/mL Solution for Injection, Adrenaline 1 Mg/mL Solution for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adrenaline 0,33 Mg/mL Solution for InjectionDrug
adrenaline dosage
Adrenaline 1 Mg/mL Solution for InjectionDrug
adrenaline dosage
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | adrenaline 0,33 mg per litter Receives: Drug: Adrenaline 0,33 Mg/mL Solution for Injection |
| Group 2 | Experimental | adrenaline 1 mg per litter Receives: Drug: Adrenaline 1 Mg/mL Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Day 1
Secondary outcomes (7)
Average blood pressure
The mean intraoperative blood pressure is the average of all measurements taken during the procedure.
Measured: Day 1
Average heart rate
The mean intraoperative heart rate is the average of all measurements taken during the procedure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Amount of saline used for the arthroscopic procedure (in litres)
Amount of saline used for the arthroscopic procedure (in litres)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start16 Jun 2022
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Rotator Cuff TendinitisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439213
- Sponsor's protocol ID
- 2021-A02773-38
- Acronym
- PINHAR
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05439213
- Acronym / sponsor ID
- PINHAR / 2021-A02773-38
- Conditions
- Shoulder Rotator Cuff Tendinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Adrenaline 0,33 Mg/mL Solution for Injectionadrenaline 0,33 mg per litter |
| Group 2 | Experimental | Drug: Adrenaline 1 Mg/mL Solution for Injectionadrenaline 1 mg per litter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adrenaline 0,33 Mg/mL Solution for Injectionadrenaline dosage | Drug | Group 1 |
| Adrenaline 1 Mg/mL Solution for Injectionadrenaline dosage | Drug | Group 2 |
Primary outcome
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.)
7 secondary outcomes
Average blood pressure
Time frame: Day 1
Average heart rate
Time frame: Day 1
Significant changes in blood pressure
Time frame: Day 1
Significant changes in heart rate
Time frame: Day 1
Evolution of the pressures of the arthropump
Time frame: Day 1
Duration of intervention
Time frame: Day 1
Amount of saline used for the arthroscopic procedure (in litres)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenaline 0,33 Mg/mL Solution for Injection and Adrenaline 1 Mg/mL Solution for Injection in people with Shoulder Rotator Cuff Tendinitis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clarity of the arthroscopic surgical field (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.