Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT03933566
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2017-12-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
US-Guided Superficial Cervical Plexus Block
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': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2017-12-29', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': 'At 15 mins after nerve block', 'description': 'Number of Participants wit absence of pain sensation for all 4 branches of the superficial cervical plexus'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound-Guided Superficial Cervical Plexus Block', 'Landmark-Based Superficial Cervical Plexus Block'], 'conditions': ['Nerve Block']}, 'descriptionModule': {'briefSummary': 'This retrospective observational study compare ultrasound-guided plane and landmark-based superficial cervical plexus block', 'detailedDescription': 'Traditionally, the superficial cervical plexus is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle.Recently, ultrasound has been used to identify intermuscular planes to carry out transversus abdominis plane and obturator nerve blocks.Thus, to validate this new method, the investigators conducted a retrospective observational study comparing ultrasound and the conventional landmark-based technique for superficial cervical plexus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '200', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing surgery of the shoulder and clavicle\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': 'NCT03933566', 'briefTitle': 'US-Guided Superficial Cervical Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine'}, 'officialTitle': 'Comparison Between Ultrasound-Guided and Landmark-Based Superficial Cervical Plexus Blockļ¼A Retrospective Observational Study', 'orgStudyIdInfo': {'id': '2019CZTCWM2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultrasound-Guided', 'description': 'Ultrasound-Guided Superficial Cervical Plexus Block', 'interventionNames': ['Procedure: Ultrasound-Guided Superficial Cervical Plexus Block']}, {'label': 'Landmark-Based', 'description': 'Landmark-Based Superficial Cervical Plexus Block', 'interventionNames': ['Procedure: Landmark-Based Superficial Cervical Plexus Block']}], 'interventions': [{'name': 'Ultrasound-Guided Superficial Cervical Plexus Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-Guided Superficial Cervical Plexus Block', 'armGroupLabels': ['Ultrasound-Guided']}, {'name': 'Landmark-Based Superficial Cervical Plexus Block', 'type': 'PROCEDURE', 'description': 'Landmark-Based Superficial Cervical Plexus Block', 'armGroupLabels': ['Landmark-Based']}]}, '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}