Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-21 @ 9:57 AM
Study NCT ID:
NCT03290404
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2017-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2017-09-20', 'lastUpdatePostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time of Block', 'timeFrame': 'Day 1', 'description': 'Minutes'}, {'measure': 'Total dose of Lidocaïne adrenaline used', 'timeFrame': 'Day 1', 'description': 'mg'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Day 1', 'description': 'questionnaire score'}], 'primaryOutcomes': [{'measure': 'Resort to an anesthesia for help in case of ineffectiveness of the block', 'timeFrame': 'Day 1', 'description': 'Yes or no Yes or No'}], 'secondaryOutcomes': [{'measure': 'Block depth', 'timeFrame': 'Day 1', 'description': 'Bromage score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Axillary Block', 'LidocaÏne 1% adrenaliné'], 'conditions': ['Axillary Block']}, 'descriptionModule': {'briefSummary': 'Axillary block is the good anesthetic technique for upper limb surgery without exceeding a certain total dose injected of Local Anesthetic (AL).\n\nThe maximal recommended dose of Lidocaine adrenaline in the upper limb is 500 mg. The use of ultrasound helps guiding the locoregional anesthesia, and allows to decrease the AL concentration, thus decreasing the risks.\n\nNo previous study estimated a concentration of lidocaine lower than 1,5 % to realize upper limb surgery by axillary block.\n\nThe literature overestimating probably the rate of failure of the locoregional anesthesia under ultrasound-guidance, we suggest to estimate the rate of failure of the axillary block ultrasound-guided with the lidocaine 1 % adrenaline for realizing upper limb surgery in standard practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult operated for the upper limb under block axillaire', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients operated for the upper limb under block axillaire\n* Adult\n* non-opposition\n\nExclusion Criteria:\n\n* medical advice to realize axillary block\n* medical advice to local anaesthetic\n* Allergy\n* Pregnant\n* ASA 3 or more'}, 'identificationModule': {'nctId': 'NCT03290404', 'acronym': 'fLACON', 'briefTitle': 'Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization', 'orgStudyIdInfo': {'id': '29BRC17.0072 fLACON'}}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Hôpital Instruction des Armées', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '29017', 'city': 'Quimper', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Cornouaille', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}