Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-01 @ 3:23 PM
Study NCT ID:
NCT02190760
Status:
UNKNOWN
Last Update Posted:
2014-07-15
First Post:
2014-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-13', 'studyFirstSubmitDate': '2014-07-13', 'studyFirstSubmitQcDate': '2014-07-13', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy DxaM Perineural', 'timeFrame': 'One day', 'description': 'Duration of motor and sensory block.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of Systemic DxaM', 'timeFrame': 'One day', 'description': 'Duration of motor and sensory block'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Analgesia']}, 'referencesModule': {'references': [{'pmid': '34554686', 'type': 'DERIVED', 'citation': 'Bei T, Liu J, Huang Q, Wu J, Zhao J. Perineural Versus Intravenous Dexamethasone for Brachial Plexus Block: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician. 2021 Sep;24(6):E693-E707.'}]}, 'descriptionModule': {'briefSummary': 'The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block. The aim of this study is to determine whether this a systemic or local effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-surgical patients for arthroscopic or open shoulder surgery\n\nExclusion Criteria:\n\n* Skin infection near block site\n* Allergy to local anesthetics\n* Peripheral neuropathy\n* Proven opioid dependency\n* Coagulopathy\n* Dementia'}, 'identificationModule': {'nctId': 'NCT02190760', 'briefTitle': 'Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of the Interscalene Brachial Plexus Block.', 'orgStudyIdInfo': {'id': 'HYMC-13.7.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (ISB-P)', 'description': 'Interscalene block with perineural injection of dexamethasone 0.1 mg/kg', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (ISB-S)', 'description': 'Interscalene block with systemically injection of dexamethasone 0.1 mg/kg.', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III - ISB-C', 'description': 'Interscalene block without adjuvant.', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['Group I (ISB-P)', 'Group II (ISB-S)']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'armGroupLabels': ['Group I (ISB-P)', 'Group II (ISB-S)', 'Group III - ISB-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Anatoly Stav, MD', 'role': 'CONTACT', 'email': 'stav@hy.health.gov.il', 'phone': '972-4-6304687'}], 'overallOfficials': [{'name': 'Anatoly Stav, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}