Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-02-25 @ 6:32 PM
Study NCT ID:
NCT03097159
Status:
WITHDRAWN
Last Update Posted:
2018-07-03
First Post:
2017-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "Surgeon refuse the proposal, so we can's enroll the patients", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-01', 'studyFirstSubmitDate': '2017-03-26', 'studyFirstSubmitQcDate': '2017-03-26', 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm palsy', 'timeFrame': '30 min', 'description': 'Using M-mode of ultrasound, compare diaphragm movement pre-block and 30min after block Paralysis : reduced movement more than 75% or paradoxical movement on sniffing Paresis : 25\\~75% movement Normal : reduced less than 25%'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['costoclavicular block'], 'conditions': ['Phrenic Nerve Paralysis']}, 'descriptionModule': {'briefSummary': 'The investigator will compare Costoclavicular approach of infraclavicular block and supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of block.', 'detailedDescription': 'Costoclavicular brachial plexus block is a recently developed approach of infraclavicular brachial plexus block. Using ultrasound, all of 3 cords are well visible in single plane. Compared to conventional infraclavicular block, it needs smaller amount of local anesthetics.\n\nSupraclavicular brachial plexus block is known as spinal anesthesia of upper extremities. It provides fast and good quality of anesthesia and analgesia. But some studies showed that there are over 50% of phrenic nerve palsy in supraclavicular block.\n\nIn this study, the investigator will compare phrenic nerve palsy incidence and block quality between Costoclavicular block and supraclavicular block using ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for surgery of hand or forearm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I or II\n* Scheduled for surgery of hand or forearm\n\nExclusion Criteria:\n\n* Patient refusal\n* Neuromuscular disease\n* Pregnancy\n* Previous history of surgery of periclavicular region\n* Nerve injury history\n* Bleeding tendency\n* Allergy to local anesthetics\n* Other contraindication of regional anesthesia'}, 'identificationModule': {'nctId': 'NCT03097159', 'acronym': 'BPB', 'briefTitle': 'Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block', 'orgStudyIdInfo': {'id': '106421'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Costoclavicular block', 'description': 'For anesthesia, this group of patients will be received ultrasound guided costoclavicular block', 'interventionNames': ['Procedure: Costoclavicular block']}, {'label': 'Supraclavicular block', 'description': 'For anesthesia, this group of patients will be received ultrasound guided supraclavicular block'}], 'interventions': [{'name': 'Costoclavicular block', 'type': 'PROCEDURE', 'description': 'Group C for costoclavicular block Group S for supraclavicular block', 'armGroupLabels': ['Costoclavicular block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16377', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou university school of medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'In Kyong Yi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant professor', 'investigatorFullName': 'In-kyong Yi', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}