Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-13 @ 5:19 PM
Study NCT ID:
NCT07093905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open-label study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of stay in the Post-Interventional Monitoring Room', 'timeFrame': 'Day 0', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Syndrome']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "This is a prospective, comparative, randomized, open-label, multicenter study comparing two analgesic strategies used in outpatient, routine surgery.\n\nThe 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.\n\nPatients 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Patients with surgically repairable complete or partial rotator cuff tears;\n* American Society of Anesthesiologists Class I to III;\n* Patient able to understand study information;\n* Patient willing to accept study evaluations and follow-up visits;\n* Affiliation with a social insurance plan;\n* Patient having been informed and having agreed to participate in the study by signing an informed consent form.\n\nExclusion Criteria:\n\n* Contraindication to general or locoregional anesthesia;\n* Chronic opioid use;\n* Patient unable to understand study information (linguistic, psychological, cognitive, etc.);\n* Patient unable to answer a self-questionnaire;\n* Patient participating in or being excluded from another interventional research study;\n* Pregnant or breast-feeding women;\n* Protected patient (under legal protection, guardianship or deprived of liberty by judicial or administrative decision).'}, 'identificationModule': {'nctId': 'NCT07093905', 'acronym': 'ALRAGA', 'briefTitle': 'Study Comparing Two Anesthetics for Arthroscopic Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Prospective, Randomized Study Comparing General Anesthesia Combined With Locoregional Anesthesia to Locoregional Anesthesia Alone for Arthroscopic Rotator Cuff Repair.', 'orgStudyIdInfo': {'id': '2025-A00971-48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Locoregional anesthesia', 'description': 'patients will benefit from locoregional anesthesia alone by means of an interscalene block of the brachial plexus.', 'interventionNames': ['Procedure: arthroscopy of the shoulder rotator cuff']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Locoregional anesthesia + general anesthesia', 'description': 'patients will benefit from general anesthesia as well as locoregional anesthesia via an interscalene block of the brachial plexus.', 'interventionNames': ['Procedure: arthroscopy of the shoulder rotator cuff']}], 'interventions': [{'name': 'arthroscopy of the shoulder rotator cuff', 'type': 'PROCEDURE', 'description': 'minimally invasive surgical procedure in which a camera (arthroscope) is inserted into the shoulder joint', 'armGroupLabels': ['Locoregional anesthesia', 'Locoregional anesthesia + general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Matthieu CHIVOT', 'role': 'CONTACT', 'email': 'chivot.matthieu@gmail.com'}], 'facility': 'Hôpital Privé Clairval', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Matthieu CHIVOT, MD', 'role': 'CONTACT', 'email': 'chivot.matthieu@gmail.com', 'phone': '662347636', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'collaborators': [{'name': 'Euraxi Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}