Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT05153902
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2021-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants requiring vasopressors in peroperative', 'timeFrame': 'during surgery (between anaesthethic induction and end of surgical procedure)', 'description': 'Number of Participants who used vasopressors in peroperative'}], 'secondaryOutcomes': [{'measure': 'Total dose of vasoconstrictor', 'timeFrame': 'during surgery (between anaesthethic induction and end of surgical procedure)', 'description': 'Total dose of vasoconstrictor'}, {'measure': 'Total time spent on vasopressor', 'timeFrame': 'during surgery (between anaesthethic induction and end of surgical procedure)', 'description': 'Total time spent on vasopressor'}, {'measure': 'Intraoperative complications', 'timeFrame': 'during surgery (between anaesthethic induction and end of surgical procedure)', 'description': 'Intraoperative complications other than hypotension'}, {'measure': 'Postoperative complications', 'timeFrame': 'between surgery and 2 days post-operative', 'description': 'nausea/vomiting; cardiovascular complications; complications related to regional anesthesia ; postoperative cognitive disorders'}, {'measure': 'total dose of rescue analgesia', 'timeFrame': 'between discharge from operating room and 24h post-operative', 'description': 'opioids'}, {'measure': 'Total time spent in the operating room', 'timeFrame': 'between arrival in the operating room and discharge from the operating room', 'description': 'Total time spent in the operating room'}, {'measure': 'Length of stay in duty or ICU', 'timeFrame': 'between the day of surgery and up to 1 month', 'description': 'Length of stay in duty or ICU'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgery', 'General Anesthesia', 'Regional anesthesia', 'Hypotension'], 'conditions': ['Proximal Humeral Fracture']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the hemodynamic impact of two anaesthetic strategies : Regional anesthesia versus General anesthesia in proximal humeral fracture surgery.', 'detailedDescription': "Proximal humeral fracture surgery is frequently performed under General Anesthesia (GA).\n\nGA is frequently associated with a high risk of hypotension with significant consequences.\n\nRegional anesthesia could be an interesting alternative to GA in order to limit hemodynamic consequences, especially in elderly patients. Furthermore, in the current state of Covid 19 crisis, regional anesthesia could provide solutions in exposing less medical staff on patient's airway.\n\nThe investigators hypothesize that the use of Regional anesthesia reduces the use of intraoperative vasopressor during surgery.\n\nAfter ethical committee approval, a retrospective cohort of patients with proximal humeral fracture, in Montpellier's University Hospital, was analyzed from 2016 to 2020. An informational note was given to all patients participating to the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Surgery for Proximal humeral fracture between january 2016 and december 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I - IV\n* Proximal humeral fracture\n* Operated between january 2016 and december 2020\n* Emergency surgery\n\nExclusion Criteria:\n\n* Surgical revision or surgery for pre-existing infection, tumour\n* Intubated patient / unconscious patient\n* Haemostasis disorder\n* Haemostasis disorder\n* Refusal of the patient'}, 'identificationModule': {'nctId': 'NCT05153902', 'acronym': 'ALR_HUMERUS', 'briefTitle': 'Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery : Comparative Study Using Propensity-score', 'orgStudyIdInfo': {'id': 'RECHMPL20_0647'}}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uh Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}