Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-24 @ 8:14 PM
Study NCT ID:
NCT00659633
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2008-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Intravenous Lidocaine on Allodynia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D006930', 'term': 'Hyperalgesia'}, {'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'C511998', 'term': 'Lidoderm'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mfroelich@uabmc.edu', 'phone': '205-975-3328', 'title': 'Dr. Michael Froelich', 'organization': 'University of Alabama at Birmigham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine', 'description': 'Intravenous lidocaine for neuropathic pain\n\nlidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Perception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine', 'description': 'Intravenous lidocaine for neuropathic pain\n\nlidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.40303', 'spread': '0.72232', 'groupId': 'OG000'}]}]}, {'title': 'Infusion', 'categories': [{'measurements': [{'value': '5.1457', 'spread': '0.72050', 'groupId': 'OG000'}]}]}, {'title': 'After Infusion', 'categories': [{'measurements': [{'value': '5.13171', 'spread': '0.72141', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be followed from baseline through 128 minutes', 'description': "Assessing heat pain perception (pain intensity) before, during, and after lidocaine infusion by means of patient self-report using a mechanical slide algometer.\n\nThe mechanical slide algometer \\[Price et al. (1994)\\] looks like a ruler that exposes a red bar with the end-points: no pain (left) and most pain imaginable (right). The use the slider to express their perceived pain. On the back of the ruler a numerical scale ranging from 0 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine', 'description': 'Intravenous lidocaine for neuropathic pain\n\nlidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine', 'description': 'Intravenous lidocaine for neuropathic pain\n\nlidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-22', 'studyFirstSubmitDate': '2008-04-14', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2008-04-14', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-06', 'studyFirstPostDateStruct': {'date': '2008-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Perception', 'timeFrame': 'Participants will be followed from baseline through 128 minutes', 'description': "Assessing heat pain perception (pain intensity) before, during, and after lidocaine infusion by means of patient self-report using a mechanical slide algometer.\n\nThe mechanical slide algometer \\[Price et al. (1994)\\] looks like a ruler that exposes a red bar with the end-points: no pain (left) and most pain imaginable (right). The use the slider to express their perceived pain. On the back of the ruler a numerical scale ranging from 0 (no pain) to 10 (worst imaginable pain) translates the patient's rating into a numeric scale."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lidocaine', 'allodynia', 'chronic regional pain syndrome', 'pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study if lidocaine, given intravenously, reduces pain.', 'detailedDescription': 'Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Regional Pain Syndrome diagnostic criteria by the Work Safe BC. vi\n\nExclusion Criteria:\n\n* History of Substance abuse\n* Other Medications: CRPS patients are expected to be treated for chronic pain, whether the current treatment regimen interferes with sensory motor testing will be determined on a case by case basis.\n* Coronary Artery Disease (CAD): unstable\n* Congestive Heart Failure (CHF): unstable\n* Heart Arrhythmia: symptomatic\n* Chronic Obstructive Pulmonary Disease (COPD)\n* Lidocaine Allergy\n* Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders, bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation.\n* Presence of Contraindications for MRI\n* Presence of electronically, magnetically, and mechanically activated implants\n* Electronically, magnetically, and mechanically activated implants\n* Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators\n* Cardiac pacemakers\n* Metallic splinters in the eye\n* Ferromagnetic haemostatic clips in the central nervous system (CNS)\n* Claustrophobia\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00659633', 'briefTitle': 'The Effect of Intravenous Lidocaine on Allodynia', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'The Effect of Intravenous Lidocaine on Allodynia (Carl Koller Grant)', 'orgStudyIdInfo': {'id': 'F061204014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'Intravenous lidocaine for neuropathic pain', 'interventionNames': ['Drug: lidocaine']}], 'interventions': [{'name': 'lidocaine', 'type': 'DRUG', 'otherNames': ['Lidoderm', 'Xylocaine'], 'description': 'intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once', 'armGroupLabels': ['Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Michael Froelich, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Society of Regional Anesthesia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Proffesor Anesthesiology M.D.', 'investigatorFullName': 'Michael Froelich', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}