Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-01-11 @ 12:41 PM
Study NCT ID:
NCT02864602
Status:
COMPLETED
Last Update Posted:
2019-03-04
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IV Dexamethasone for Prolongation of Peripheral Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The duration of sensory anesthesia and analgesia following median nerve block', 'timeFrame': 'This will be assessed for up to 12 hours following block'}], 'secondaryOutcomes': [{'measure': 'The duration of motor block following median nerve block', 'timeFrame': 'This will be assessed for up to 12 hours following block'}, {'measure': 'Side effects related to nerve block or IV infusion of dexamethasone', 'timeFrame': 'Volunteers will be phoned at 24-36 hrs and then 7-10 days to ensure full resolution of the block'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Regional anesthesia', 'Adjuvant', 'Dexamethasone'], 'conditions': ['Anesthesia, Conduction']}, 'referencesModule': {'references': [{'pmid': '31711605', 'type': 'DERIVED', 'citation': 'Short A, El-Boghdadly K, Clarke H, Komaba T, Jin R, Chin KJ, Chan V. Effect of intravenous dexamethasone on the anaesthetic characteristics of peripheral nerve block: a double-blind, randomised controlled, dose-response volunteer study. Br J Anaesth. 2020 Jan;124(1):92-100. doi: 10.1016/j.bja.2019.08.029. Epub 2019 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'This is a volunteer study examining the effect of different doses of IV dexamethasone on prolongation of median nerve block in the forearm.', 'detailedDescription': '18 healthy volunteers aged 18-50 will be recruited (6 patients in each dosing group). Each volunteer will receive two forearm median nerve blocks separated by a two week washout period. One block will be conducted alongside an infusion of normal saline (control). The other block will be conducted alongside a randomised dose of IV dexamethasone (2, 4 or 8mg). The order of these interventions will be random. Blocks will be assessed quantitatively with cold and sharp sensation, electrical stimulation, quantitative sensory testing (thermal tolerance) and grip strength dynamometry. Measures or sensory and motor block including onset, intensity and duration will be compared between dosing groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1 (normal healthy) volunteers.\n* 18 - 50 years of age.\n* 60 - 100kg weight.\n* English speaking.\n* Female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate.\n* Females of child bearing potential must be willing to use medically acceptable birth control methods between study interventions and for a minimum of 2 weeks following the second nerve block.\n\nExclusion Criteria:\n\n* Medical disorders (including bleeding disorders).\n* Use of systemic steroids within 2 weeks of the study, prescription medications, live viral vaccines or any recreational drug use.\n* Hypersensitivity to bupivacaine, dexamethasone or any component of saline.\n* Contraindication to regional anesthetic block.\n* Inability to provide informed consent.\n* Baseline abnormality of hand sensation or motor function.\n* Pregnancy / breast feeding.\n* Individuals with mental health disorders (for example bipolar disorder or depression).\n* Individuals with cataracts or glaucoma.\n* Any known contraindication to IV dexamethasone as per the product monograph - bacteremia and systemic fungal infections, hypersensitivity to any of the products components, gastric and duodenal ulcers, certain viral infections i.e. varicella herpes genitalis.'}, 'identificationModule': {'nctId': 'NCT02864602', 'briefTitle': 'IV Dexamethasone for Prolongation of Peripheral Nerve Block', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Volunteer Study to Determine the Optimal Dose of IV Dexamethasone Required for Prolongation of Peripheral Nerve Block', 'orgStudyIdInfo': {'id': '15-5049-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone 2mg', 'description': 'The experimental intervention in this arm will be an IV infusion of 2mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).', 'interventionNames': ['Drug: IV dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Dexamethasone 4mg', 'description': 'The experimental intervention in this arm will be an IV infusion of 4mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).', 'interventionNames': ['Drug: IV dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Dexamethasone 8mg', 'description': 'The experimental intervention in this arm will be an IV infusion of 8mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).', 'interventionNames': ['Drug: IV dexamethasone']}], 'interventions': [{'name': 'IV dexamethasone', 'type': 'DRUG', 'otherNames': ['Dexamethasone sodium phosphate injection USP'], 'description': 'An infusion of IV dexamethasone', 'armGroupLabels': ['Dexamethasone 2mg', 'Dexamethasone 4mg', 'Dexamethasone 8mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}