Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-08 @ 11:49 PM
Study NCT ID:
NCT02658760
Status:
UNKNOWN
Last Update Posted:
2016-10-13
First Post:
2016-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine and Bupivacaine With Bupivacaine in Ultrasonography Guided Fascia Iliaca Compartment Block in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2016-01-15', 'studyFirstSubmitQcDate': '2016-01-15', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '24 hours', 'description': 'A point between 0 and 10 based on patient report'}], 'secondaryOutcomes': [{'measure': 'Respiratory depression', 'timeFrame': '24 hours', 'description': 'respiratory rate \\< 12/min'}, {'measure': 'Hypotension', 'timeFrame': '24 hours', 'description': 'Systolic blood pressure \\< 90 mmHg'}, {'measure': 'Baradycardia', 'timeFrame': '24 hours', 'description': 'Heart rate \\< 60/min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Femoral Fractures'], 'conditions': ['Femoral Fractures']}, 'descriptionModule': {'briefSummary': 'Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine alone on the quality of ultrasonography guided fascia iliaca compartment block in adults undergoing femur fracture fixation surgery at 2014.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with femural fracture\n\nExclusion Criteria:\n\n* Hypersensitivity to drugs\n* Neurological diseases\n* Coagulation abnormalities\n* Infection at the site of block'}, 'identificationModule': {'nctId': 'NCT02658760', 'briefTitle': 'Dexmedetomidine and Bupivacaine With Bupivacaine in Ultrasonography Guided Fascia Iliaca Compartment Block in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Hormozgan University of Medical Sciences'}, 'officialTitle': 'Comparison of Dexmedetomidine and Bupivacaine With Bupivacaine Alone on the Quality of Ultrasonography Guided Fascia Iliaca Compartment Block in Adults Undergoing Femur Fracture Fixation Surgery', 'orgStudyIdInfo': {'id': 'Hums.Rec.1394.74'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine', 'description': '30cc of 0.25% bupivacaine', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine and bupivacaine', 'description': '30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Bupivacaine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'dexmedetomidine plus placebo', 'armGroupLabels': ['Dexmedetomidine and bupivacaine']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'dexmedetomidine and Bupivacaine', 'armGroupLabels': ['Bupivacaine', 'Dexmedetomidine and bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79176', 'city': 'Bandar Abbas', 'state': 'Hormozgan', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Hamidreza Mahboobi', 'role': 'CONTACT', 'email': 'hamidrezamahboobi@yahoo.com', 'phone': '09809364300250'}, {'name': 'Hamidreza Mahboobi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shahid Mohammadi hospital', 'geoPoint': {'lat': 27.1865, 'lon': 56.2808}}], 'centralContacts': [{'name': 'Hamidreza Mahboobi', 'role': 'CONTACT', 'email': 'hamidrezamahboobi@yahoo.com', 'phone': '9172121995', 'phoneExt': '+98'}], 'overallOfficials': [{'name': 'Nasim Abdi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hormozgan University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamidreza Mahboobi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Hamidreza Mahboobi', 'investigatorAffiliation': 'Hormozgan University of Medical Sciences'}}}}