Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-27 @ 5:24 AM
Study NCT ID:
NCT00725504
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2008-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of IV Lidocaine Infusions on Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smackey@pain.stanford.edu', 'phone': '(650) 498-6477', 'title': 'Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected during the infusion period (approximately one hour) for each participant.', 'description': 'The definitions for adverse event and serious adverse event did not differ from clinicaltrials.gov.', 'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine Infusion', 'description': 'Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.', 'otherNumAtRisk': 71, 'otherNumAffected': 9, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Transient central nervous system side effects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Present Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Each participant was tested at the zero infusion rate.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Each participant received a placebo-saline infusion.'}, {'id': 'OG002', 'title': 'Lidocaine 3 µg/ml', 'description': 'Each participant received an intravenous infusion of 3 µg/ml of lidocaine.'}, {'id': 'OG003', 'title': 'Lidocaine 5 µg/ml', 'description': 'Each participant received an intravenous infusion of 5 µg/ml of lidocaine.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.25', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '5.64', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '4.92', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '4.18', 'spread': '0.28', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Patients completed the VAS of present pain intensity immediately before and immediately after placebo and during each infusion level', 'description': 'Present pain intensity was measured using the visual analog scale (VAS). This is scored between 0 (no pain) to 10 (worst possible pain).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine Infusion', 'description': 'Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml.\n\nIntravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '71 patients were recruited through the Stanford University Pain Management Center.', 'preAssignmentDetails': 'Individuals were assessed for neuropathic pain prior to enrollment. Those with co-morbid cardiac disease were excluded from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine Infusion', 'description': 'Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml.\n\nIntravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '82'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Seventy-one patients with chronic neuropathic pain'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-24', 'studyFirstSubmitDate': '2008-07-28', 'resultsFirstSubmitDate': '2017-03-04', 'studyFirstSubmitQcDate': '2008-07-28', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-04', 'studyFirstPostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Present Pain Intensity', 'timeFrame': 'Patients completed the VAS of present pain intensity immediately before and immediately after placebo and during each infusion level', 'description': 'Present pain intensity was measured using the visual analog scale (VAS). This is scored between 0 (no pain) to 10 (worst possible pain).'}]}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Our goals for this study involve using intravenous lidocaine as it is normally used in the Stanford Pain Management Center to assess the effect of intravenous lidocaine on chronic pain. Studies have been done determining the efficacy of intravenous lidocaine for treating pain but little research has been done to determine the effects of an intravenous lidocaine infusion on the different components of the pain experience. Our study will incorporate pain quality measures both before and during the infusions of lidocaine to determine changes in present pain intensity.', 'detailedDescription': 'Each patient will receive an intravenous infusion of lidocaine. Drug will be infused using a computer-controlled paradigm. This paradigm allows increasing plasma concentrations in a step-wise manner, keeping the concentration during each infusion step constant. Plasma concentrations will be increased gradually from 0 to 5 ug/ml in a method at the discretion of the medical team. This will be conducted according to standard medical practice for the infusion and the study procedures will not affect the infusion paradigm. Total infusion time is approximately 1-2 hours. During the course of the study, the primary outcome measure was changed from blood oxygenation level dependent (BOLD) signal to pain intensity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:- subjects between the ages of 18 and 100 years for clinical component; subjects between the ages of 18 and 70 for the MRI component\n\n* meets the study criteria of chronic pain of either peripheral or central origin\n* male or a non-pregnant, non-lactating female. If females are of reproductive potential (i.e., not surgically sterilized and/or not post menopausal), they must be practicing an accepted method of birth control, agree to a urine pregnancy test at the start of each study session (for patient scheduled through the clinic, this has already been addressed by the recommending physician)\n* is not currently on a sodium channel blocking agent, anticonvulsant, or tricyclic antidepressant,\n* must be able to comply with any other study requirements and complete experimental tasks\n* have no reported substance abuse within the past six months; Exclusion Criteria:- subject is lactating or pregnant;\n* subject suffers from clinically significant cardiac, pulmonary, renal or liver disease;\n* subject allergic to lidocaine.\n* MRI Component: any metal objects (especially surgical clips), devices, or implants or any other MRI contraindication'}, 'identificationModule': {'nctId': 'NCT00725504', 'briefTitle': 'Effect of IV Lidocaine Infusions on Pain', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Effect of IV Lidocaine Infusions on Pain', 'orgStudyIdInfo': {'id': 'SU-07072008-1232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine infusion', 'description': 'Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.', 'interventionNames': ['Drug: Intravenous lidocaine']}], 'interventions': [{'name': 'Intravenous lidocaine', 'type': 'DRUG', 'description': 'Intravenous lidocaine administered up to 5 µg/ml.', 'armGroupLabels': ['Lidocaine infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Sean Mackey', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sean Mackey', 'investigatorAffiliation': 'Stanford University'}}}}