Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-28 @ 2:49 PM
Study NCT ID:
NCT02961361
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2016-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001134', 'term': 'Arm Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2016-10-22', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration time', 'timeFrame': 'once per hour after surgery until 24 hours after surgery', 'description': 'effective analgesia time'}], 'secondaryOutcomes': [{'measure': 'onset time', 'timeFrame': '5,10,15,20,25,30 min after injection'}, {'measure': 'Visual analogue scale', 'timeFrame': '2,6,12,24hour after injection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'coracoid', 'brachial plexus block'], 'conditions': ['Injury of Upper Limb']}, 'referencesModule': {'references': [{'pmid': '30278495', 'type': 'DERIVED', 'citation': 'He WS, Liu Z, Wu ZY, Sun HJ, Yang XC, Wang XL. The effect of dexmedetomidine in coracoid approach brachial plexus block under dual stimulation. Medicine (Baltimore). 2018 Sep;97(39):e12240. doi: 10.1097/MD.0000000000012240.'}]}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine is an α-2 adrenoreceptor agonist and has been extensively used through intravenous infusion，in order to improved the quality of block in regional anesthesia. In this prospective, randomized study, the authors focus on the effect of dexmedetomidine mixed with ropivacaine in coracoid approach brachial plexus block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. American Society of Anesthesiologists (ASA) physical status I or II;\n2. Aged 18-60 years;\n3. The elbow, forearm, wrist or hand surgery\n\nExclusion Criteria:\n\n1. History of allergy to local anesthetics;\n2. Coagulation dysfunction, neuromuscular disease or local infection;\n3. The operation time is longer than the local anesthetics effective time.'}, 'identificationModule': {'nctId': 'NCT02961361', 'briefTitle': 'the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The First Hospital of Qinhuangdao'}, 'officialTitle': 'the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block', 'orgStudyIdInfo': {'id': 'Dex'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Control', 'description': '40 ml 0.375% ropivacaine was injected after Locating brachial plexus.', 'interventionNames': ['Drug: ropivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Group Dexmedetomidine', 'description': '40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.', 'interventionNames': ['Drug: ropivacaine mixed with dexmedetomidine']}], 'interventions': [{'name': 'ropivacaine', 'type': 'DRUG', 'description': '40 ml 0.375% ropivacaine was injected after Locating brachial plexus.', 'armGroupLabels': ['Group Control']}, {'name': 'ropivacaine mixed with dexmedetomidine', 'type': 'DRUG', 'description': '40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.', 'armGroupLabels': ['Group Dexmedetomidine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'wensheng he, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebei Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Qinhuangdao', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}