Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-04 @ 5:41 PM
Study NCT ID:
NCT06641167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Soft Point Anesthesia in Association With Locoregional Anesthesia in Arthroscopic Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Soft point position', 'timeFrame': 'Hour 24', 'description': 'The primary outcome is the position of the soft point in relation to the anesthetized area mapped by loco-regional anesthesia'}], 'secondaryOutcomes': [{'measure': 'Incision pain', 'timeFrame': 'Hour 24', 'description': 'Assessment of incision pain using a simple numerical scale (NRS) from 0 (no pain/not uncomfortable) to 10 (worst possible pain/most uncomfortable)'}, {'measure': 'Postoperative pain', 'timeFrame': 'Hour 2', 'description': 'Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)'}, {'measure': 'Postoperative pain', 'timeFrame': 'Hour 6', 'description': 'Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)'}, {'measure': 'Postoperative pain', 'timeFrame': 'Hour 24', 'description': 'Assessment of postoperative pain using a simple numerical scale (NRS) from 0 (no pain) to 10 (worst possible pain)'}, {'measure': 'Sedative medication', 'timeFrame': 'Hour 24', 'description': 'Amount of sedative medication administered'}, {'measure': 'Analgesic consumption', 'timeFrame': 'Hour 24', 'description': 'Amount of analgesics consumed within the 24 hours following surgery'}, {'measure': 'Intervention duration', 'timeFrame': 'Hour 24', 'description': 'Duration of the procedure and stay in the Post anesthesia care unit (the procedure duration is defined as the time between the start of the incision and the end of suturing)'}, {'measure': 'Stay in the PACU duration', 'timeFrame': 'Hour 24', 'description': 'Duration of the procedure and stay in the Post anesthesia care unit (the procedure duration is defined as the time between the start of the incision and the end of suturing)'}, {'measure': 'Adverse events', 'timeFrame': 'Hour 24', 'description': 'Perioperative and immediate postoperative adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-center, observational study. The inclusion period is set at 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'population of patients undergoing shoulder surgery by arthroscopic approach under locoregional anesthesia combining an interscalene block and a superficial cervical plexus block (supraclavicular nerve)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Patient informed about the study and who has not opposed the use of their personal medical data\n* Patient scheduled for arthroscopic shoulder surgery\n\nExclusion Criteria:\n\n* Allergy to local anesthetics or epinephrine\n* Contraindications to Interscalene Block (e.g., respiratory disease, pneumothorax, pneumonectomy, phrenic or recurrent laryngeal nerve paralysis)\n* Coagulation disorder\n* Patients unable to understand the study information and objectives: dementia, psychosis, consciousness disorders, non-French-speaking patients\n* Patients under legal protection measures (guardianship, curatorship) or deprived of liberty by judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT06641167', 'acronym': 'CAESAR', 'briefTitle': 'Interest of Soft Point Anesthesia in Association With Locoregional Anesthesia in Arthroscopic Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Interest of Soft Point Anesthesia in Association With Locoregional Anesthesia in Arthroscopic Shoulder Surgery', 'orgStudyIdInfo': {'id': '2024-06-007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Shoulder surgery', 'type': 'PROCEDURE', 'description': 'shoulder surgery by arthroscopic approach under locoregional anesthesia combining an interscalene block and a superficial cervical plexus block'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91480', 'city': 'Quincy-sous-Sénart', 'country': 'France', 'contacts': [{'name': 'Yoann ELMALEH, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital privé Claude Galien', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}], 'centralContacts': [{'name': 'Yoann ELMALEH, MD', 'role': 'CONTACT', 'email': 'yoann.d.elmaleh@gmail.com', 'phone': '01 69 39 15 53', 'phoneExt': '33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}