Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT01091935
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
2010-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of Intravenous Lidocaine Infusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-23', 'studyFirstSubmitDate': '2010-03-22', 'studyFirstSubmitQcDate': '2010-03-23', 'lastUpdatePostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lidocaine,Intravenous Infusions,Neuropathic Pain,Side Effects'], 'conditions': ['Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '10680784', 'type': 'BACKGROUND', 'citation': 'Attal N, Gaude V, Brasseur L, Dupuy M, Guirimand F, Parker F, Bouhassira D. Intravenous lidocaine in central pain: a double-blind, placebo-controlled, psychophysical study. Neurology. 2000 Feb 8;54(3):564-74. doi: 10.1212/wnl.54.3.564.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively determine the side effects profile in adults with neuropathic pain receiving intravenous infusions of lidocaine 5 mg per kg of lean body weight, infused over 45 minutes.', 'detailedDescription': "Eligibility Criteria:\n\nAdults \\> 18 yrs with chronic central or peripheral neuropathic pain at the St Joseph's Health Care Pain Clinic between June and December 2009.\n\nOutcome measures: All side effects spontaneously reported. Sedation, nausea, dizziness by Visual Analog Score Q 15 minutes; hemodynamic data q 5 minutes during and after infusion for 30 minutes.\n\nDaily diary of side effects and Visual Analogue score of Pain for 7 days post-infusion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult outpatients attending St Joseph's Chronic Pain Clinic in one of two time periods who have been diagnosed with chronic neuropathic pain by clinical history and examination and are scheduled to receive a lidocaine infusion for pain management", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult outpatients \\> 18 years \\< 80 years diagnosed with chronic neuropathic pain\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Unable to speak and understand English\n* Liver, kidney, or cardiac failure\n* Allergy to Lidocaine'}, 'identificationModule': {'nctId': 'NCT01091935', 'briefTitle': 'Safety of Intravenous Lidocaine Infusions', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Safety of Intravenous Lidocaine Infusions for Chronic Neuropathic Pain', 'orgStudyIdInfo': {'id': 'R-08-341'}, 'secondaryIdInfos': [{'id': '15240E', 'type': 'OTHER', 'domain': 'REB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lidocaine', 'description': "Adults \\>18 yrs , attending St Joseph's Health Care Pain Clinic with a diagnosis of chronic neuropathic pain who are being treated with an lidocaine infusion of 5 mg/kg over 45 minutes\n\nConsecutive patients from two time periods:\n\n1. June 15 to August 21, 2009\n2. October 15-Dec 22,2009"}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St Joseph's Health Care", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Patricia K Morley-Forster, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor,Dept of Anesthesia and Perioperative Medicine,University of Western Ontario, Lawson Health Research Institute'}, {'name': 'Patricia K Morley-Forster, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor, University of Western Ontario, Lawson Health Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Patricia Morley-Forster', 'oldOrganization': "St Joseph's Health Care"}}}}