Rotator Cuff SyndromeALRAGANCT07093905
Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair
A study testing arthroscopy of the shoulder rotator cuff in people with Rotator Cuff Syndrome, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of this study is to to compare the post-anesthetic recovery time to awake consciousness and hemodynamic and ventilatory capacities for discharge from the Post-Interventional Monitoring Room in patients admitted for shoulder rotator cuff arthroscopy (using local anesthesia versus general anesthesia + local… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Syndrome
- What is being tested?
- arthroscopy of the shoulder rotator cuff
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years;
- Patients with surgically repairable complete or partial rotator cuff tears;
- American Society of Anesthesiologists Class I to III;
- Patient able to understand study information;
- Patient willing to accept study evaluations and follow-up visits;
- Affiliation with a social insurance plan;
- Patient having been informed and having agreed to participate in the study by signing an informed consent form.
Who cannot join
- Contraindication to general or locoregional anesthesia;
- Chronic opioid use;
- Patient unable to understand study information (linguistic, psychological, cognitive, etc.);
- Patient unable to answer a self-questionnaire;
- Patient participating in or being excluded from another interventional research study;
- Pregnant or breast-feeding women;
- Protected patient (under legal protection, guardianship or deprived of liberty by judicial or administrative decision).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Clairval
Marseille, 13009
Matthieu CHIVOT, chivot.matthieu@gmail.com
About this study
Official title: Prospective, Randomized Study Comparing General Anesthesia Combined With Locoregional Anesthesia to Locoregional Anesthesia Alone for Arthroscopic Rotator Cuff Repair.
The purpose of this study is to to compare the post-anesthetic recovery time to awake consciousness and hemodynamic and ventilatory capacities for discharge from the Post-Interventional Monitoring Room in patients admitted for shoulder rotator cuff arthroscopy (using local anesthesia versus general anesthesia + local anesthesia).
Read the detailed description
This is a prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies used in outpatient, routine surgery.
The study population is composed of adult patients with complete or partial rotator cuff tears requiring reconstructive surgery under anesthesia at Hôpital Privé Clairval or Clinique Monticelli-Vélodrome.
Patients will be seen three times: at inclusion (during the preoperative consultation with the anesthetist), on the day of surgery (hospitalization), and at the follow-up visit (during the postoperative consultation with the surgeon). They will also be contacted by telephone on D1, D3 and D15 to optimize their follow-up. The duration of each patient's participation is approximately one month.
- Conditions
- Rotator Cuff Syndrome
- Being tested
- arthroscopy of the shoulder rotator cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopy of the shoulder rotator cuffProcedure or surgery
minimally invasive surgical procedure in which a camera (arthroscope) is inserted into the shoulder joint
| Study group | Role | What they receive |
|---|---|---|
| Locoregional anesthesia | Experimental | patients will benefit from locoregional anesthesia alone by means of an interscalene block of the brachial plexus. Receives: Procedure: arthroscopy of the shoulder rotator cuff |
| Locoregional anesthesia + general anesthesia | Active comparator | patients will benefit from general anesthesia as well as locoregional anesthesia via an interscalene block of the brachial plexus. Receives: Procedure: arthroscopy of the shoulder rotator cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay in the Post-Interventional Monitoring Room
The primary endpoint is the length of stay in the Post-Interventional Monitoring Room from discharge from the operating room to an Aldrete score > 8 leading to discharge from the Post-Interventional Monitoring Room.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start12 Mar 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093905
- Sponsor's protocol ID
- 2025-A00971-48
- Acronym
- ALRAGA
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study Comparing General Anesthesia Combined With Locoregional Anesthesia to Locoregional Anesthesia Alone for Arthroscopic Rotator Cuff Repair.
- ClinicalTrials.gov ID
- NCT07093905
- Acronym / sponsor ID
- ALRAGA / 2025-A00971-48
- Conditions
- Rotator Cuff Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 30 Jul 2025 (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 purpose of this study is to to compare the post-anesthetic recovery time to awake consciousness and hemodynamic and ventilatory capacities for discharge from the Post-Interventional Monitoring Room in patients admitted for shoulder rotator cuff arthroscopy (using local anesthesia versus general anesthesia + local anesthesia).
Detailed description
This is a prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies used in outpatient, routine surgery.
The study population is composed of adult patients with complete or partial rotator cuff tears requiring reconstructive surgery under anesthesia at Hôpital Privé Clairval or Clinique Monticelli-Vélodrome.
Patients will be seen three times: at inclusion (during the preoperative consultation with the anesthetist), on the day of surgery (hospitalization), and at the follow-up visit (during the postoperative consultation with the surgeon). They will also be contacted by telephone on D1, D3 and D15 to optimize their follow-up. The duration of each patient's participation is approximately one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies
| Arm | Type | Receives |
|---|---|---|
| Locoregional anesthesia | Experimental | Procedure: arthroscopy of the shoulder rotator cuffpatients will benefit from locoregional anesthesia alone by means of an interscalene block of the brachial plexus. |
| Locoregional anesthesia + general anesthesia | Active comparator | Procedure: arthroscopy of the shoulder rotator cuffpatients will benefit from general anesthesia as well as locoregional anesthesia via an interscalene block of the brachial plexus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years;
- Patients with surgically repairable complete or partial rotator cuff tears;
- American Society of Anesthesiologists Class I to III;
- Patient able to understand study information;
- Patient willing to accept study evaluations and follow-up visits;
Key exclusion criteria (7 listed)
- Contraindication to general or locoregional anesthesia;
- Chronic opioid use;
- Patient unable to understand study information (linguistic, psychological, cognitive, etc.);
- Patient unable to answer a self-questionnaire;
- Patient participating in or being excluded from another interventional research study;
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 |
|---|---|---|
| arthroscopy of the shoulder rotator cuffminimally invasive surgical procedure in which a camera (arthroscope) is inserted into the shoulder joint | Procedure or surgery | Locoregional anesthesia, Locoregional anesthesia + general anesthesia |
Primary outcome
length of stay in the Post-Interventional Monitoring Room
Time frame: Day 0
The primary endpoint is the length of stay in the Post-Interventional Monitoring Room from discharge from the operating room to an Aldrete score > 8 leading to discharge from the Post-Interventional Monitoring Room.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopy of the shoulder rotator cuff in people with Rotator Cuff Syndrome, 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthieu CHIVOT, MD (662347636 ext. +33, chivot.matthieu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay in the Post-Interventional Monitoring Room (time frame: Day 0). 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 16 Sep 2026.