Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-13 @ 5:35 PM
Study NCT ID:
NCT03933228
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2019-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesia for Clavicular Fracture and Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2019-04-28', 'studyFirstSubmitQcDate': '2019-04-28', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Block success rate', 'timeFrame': 'At time 15 minutes after the block', 'description': 'Sensory blockade was assessed using the pinprick test at the surgery site'}], 'secondaryOutcomes': [{'measure': 'Acute complications', 'timeFrame': 'At the end of surgery immediately', 'description': 'Number of participants with phrenic nerve palsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Combined Interscalene-Cervical Plexus Block', 'Combined Supraclavicular-Cervical Plexus Block'], 'conditions': ['Clavicular Fractures']}, 'descriptionModule': {'briefSummary': 'Compared efficacy of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.', 'detailedDescription': 'The primary objective of this study was to compare the effectiveness of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.The hypothesis of this study was that the supraclavicular-cervical plexus block could provide better anesthesia with less anesthesia related complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '150', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgery of the clavicular fractures under combined cervical plexus plus brachial plexus block\n* Urgent or planned surgery\n\nExclusion Criteria:\n\n* Refused to sign informed consent\n* Pregnant women\n* Allergic to the local anesthetic'}, 'identificationModule': {'nctId': 'NCT03933228', 'briefTitle': 'Analgesia for Clavicular Fracture and Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine'}, 'officialTitle': 'Ultrasound-Guided Combined Interscalene-Cervical Plexus Versus Combined Supraclavicular-Cervical Plexus Block for Surgical Anesthesia in Clavicular Fractures: A Retrospective Observational Study', 'orgStudyIdInfo': {'id': '2019CZTCWM4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interscalene-Cervical Plexus Block', 'description': 'Ultrasound-Guided Combined Interscalene-Cervical Plexus Block', 'interventionNames': ['Procedure: Interscalene-Cervical Plexus Block']}, {'label': 'Supraclavicular-Cervical Plexus Block', 'description': 'Ultrasound-Guided Combined Supraclavicular-Cervical Plexus Block', 'interventionNames': ['Procedure: Supraclavicular-Cervical Plexus Block']}], 'interventions': [{'name': 'Interscalene-Cervical Plexus Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-Guided Combined Interscalene-Cervical Plexus Block', 'armGroupLabels': ['Interscalene-Cervical Plexus Block']}, {'name': 'Supraclavicular-Cervical Plexus Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-Guided Combined Supraclavicular-Cervical Plexus Block', 'armGroupLabels': ['Supraclavicular-Cervical Plexus Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '061001', 'city': 'Cangzhou', 'state': 'Hebei', 'country': 'China', 'facility': 'Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine', 'geoPoint': {'lat': 38.31124, 'lon': 116.85334}}], 'overallOfficials': [{'name': 'Ruizhao Lv, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}