Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-25 @ 1:46 AM
Study NCT ID:
NCT01968694
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2013-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Intravenous Lidocaine on Endometriosis Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004155', 'term': 'Diphenhydramine'}], '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'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abarreveld@partners.org', 'phone': '617-243-6298', 'title': 'Dr. Antje M Barreveld', 'organization': "Brigham & Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'IV Lidocaine', 'description': 'IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IV Diphenhydramine', 'description': 'IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Washout Period After IV Lidocaine', 'description': 'Washout period after IV Lidocaine before IV diphenhydramine', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Washout Period After IV Diphenhydramine', 'description': 'Washout period after IV diphenhydramine before IV Lidocaine', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Lidocaine', 'description': 'IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes'}, {'id': 'OG001', 'title': 'IV Diphenhydramine', 'description': 'IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes'}], 'classes': [{'title': '15 minutes after start of infusion change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '-0.8'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '0'}]}]}, {'title': '30 minutes after start of infusion change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '-2.3'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '-0.1'}]}]}, {'title': '30 minutes after infusion complete change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'groupId': 'OG000', 'lowerLimit': '-4.6', 'upperLimit': '-0.6'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)', 'description': 'Visual Analogue Scale (VAS) ranges from 0 (no pain) to 10 (the worse imaginable pain).\n\nChange scores are calculated from baseline (pre-infusion) at 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete:\n\n(15 minutes after start of infusion value - BL pre-infusion value) (30 minutes after start of infusion value - BL pre-infusion value) (30 minutes after infusion complete value - BL pre-infusion value)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion started.\n\n3 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion complete.'}, {'type': 'SECONDARY', 'title': 'Change in Short Form McGill Pain Questionnaire 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Lidocaine', 'description': 'IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes'}, {'id': 'OG001', 'title': 'IV Diphenhydramine', 'description': 'IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes'}], 'classes': [{'title': '30 minutes change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.5', 'groupId': 'OG000', 'lowerLimit': '-46', 'upperLimit': '-8'}, {'value': '-15', 'groupId': 'OG001', 'lowerLimit': '-30', 'upperLimit': '-4'}]}]}, {'title': '1 week change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18', 'groupId': 'OG000', 'lowerLimit': '-43', 'upperLimit': '-4'}, {'value': '-17', 'groupId': 'OG001', 'lowerLimit': '-30', 'upperLimit': '-6'}]}]}, {'title': '1 month change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '-35', 'upperLimit': '24'}, {'value': '-18', 'groupId': 'OG001', 'lowerLimit': '-26', 'upperLimit': '-11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)', 'description': "Short-form McGill Pain Questionnaire version 2 consists of 22 pain items (Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, Punishing-cruel, Electric-shock, Cold-freezing, Piercing, Pain caused by light touch, Itching, Tingling or 'pins and needles', and Numbness). Each item is rated on a scale from 0-10, where 0=none, and 10=worst possible pain. The total pain score is the sum of these 22 items, ranging from 0-220.\n\nChange scores are calculated from baseline (pre-infusion) at 30 minutes, 1 week, and 1 month post-treatment:\n\n(30 minutes post-treatment value - BL pre-infusion value)\n\n(1 week post-treatment value - BL pre-infusion value)\n\n(1 month post-treatment value - BL pre-infusion value)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '1. participant in the IV diphenhydramine arm is missing SFMPQ total score 1 week post-treatment.\n2. participants in the IV diphenhydramine arm are missing SFMPQ total score 1 month post-treatment.\n3. participants in the IV Lidocaine arm are missing SFMPQ total score 1 month post-treatment.'}, {'type': 'SECONDARY', 'title': 'Change in Brief Pain Inventory (BPI): Pain on Average', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Lidocaine', 'description': 'IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes'}, {'id': 'OG001', 'title': 'IV Diphenhydramine', 'description': 'IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes'}], 'classes': [{'title': '1 day change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '1'}]}]}, {'title': '1 week change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}, {'title': '1 month change from BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)', 'description': 'The Pain on Average score in the Brief Pain Inventory is rated from 0-10, where 0 is no pain, and 10 is pain as bad as you can imagine.\n\nChange scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:\n\n(1 day post-treatment value - BL pre-infusion value)\n\n(1 week post-treatment value - BL pre-infusion value)\n\n(1 month post-treatment value - BL pre-infusion value)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'In the IV diphenhydramine arm 1 pt is missing BPI avg pain score at 1 week, and 2 are missing scores at 1 month. In the IV Lidocaine arm 1 pt is missing a score at 1 day, 1 is missing a score at 1 week, and 4 are missing scores at 1 month.'}, {'type': 'SECONDARY', 'title': 'Change in Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Lidocaine', 'description': 'IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes'}, {'id': 'OG001', 'title': 'IV Diphenhydramine', 'description': 'IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes'}], 'classes': [{'title': 'Anxiety 1 day change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}, {'title': 'Anxiety 1 week change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-1'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '0'}]}]}, {'title': 'Anxiety 1 month change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-2.5', 'upperLimit': '0'}]}]}, {'title': 'Depression 1 day change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}, {'title': 'Depression 1 week change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-1'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '0'}]}]}, {'title': 'Depression 1 month change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)', 'description': 'The Hospital Anxiety and Depression Scale (HADS) consists of 14 items rated from 0-3 and 2 subscales Depression (7 items) and Anxiety (7 items). A higher score on each item represents more of each symptom (i.e., more depression or more anxiety). Each subscale score is the sum of the 7 items from each subscale.\n\nA score of 0-7 = Normal, 8-10=Borderline abnormal (borderline case), and 11-21=Abnormal (case).\n\nChange scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:\n\n(1 day post-treatment value - BL pre-infusion value)\n\n(1 week post-treatment value - BL pre-infusion value)\n\n(1 month post-treatment value - BL pre-infusion value)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'In the IV diphenhydramine arm 1 pt is missing HADS scores at 1 week, and 3 pts are missing scores at 1 month. In the IV Lidocaine arm 3 pts are missing HADS scores at 1 month.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV Lidocaine Then IV Diphenhydramine', 'description': 'IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.\n\nIV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.'}, {'id': 'FG001', 'title': 'IV Diphenhydramine Then IV Lidocaine', 'description': 'IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.\n\nIV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.'}], 'periods': [{'title': 'Visit 1 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (1 Month)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Visit 2 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Only 19 of the 20 enrolled started the study because one participant did not participate past consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IV Lidocaine Then IV Diphenhydramine', 'description': 'IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.\n\nIV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.'}, {'id': 'BG001', 'title': 'IV Diphenhydramine Then IV Lidocaine', 'description': 'IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.\n\nIV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2013-10-21', 'resultsFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2013-10-21', 'lastUpdatePostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-11', 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Visual Analogue Scale (VAS)', 'timeFrame': '15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)', 'description': 'Visual Analogue Scale (VAS) ranges from 0 (no pain) to 10 (the worse imaginable pain).\n\nChange scores are calculated from baseline (pre-infusion) at 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete:\n\n(15 minutes after start of infusion value - BL pre-infusion value) (30 minutes after start of infusion value - BL pre-infusion value) (30 minutes after infusion complete value - BL pre-infusion value)'}], 'secondaryOutcomes': [{'measure': 'Change in Short Form McGill Pain Questionnaire 2', 'timeFrame': '30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)', 'description': "Short-form McGill Pain Questionnaire version 2 consists of 22 pain items (Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, Punishing-cruel, Electric-shock, Cold-freezing, Piercing, Pain caused by light touch, Itching, Tingling or 'pins and needles', and Numbness). Each item is rated on a scale from 0-10, where 0=none, and 10=worst possible pain. The total pain score is the sum of these 22 items, ranging from 0-220.\n\nChange scores are calculated from baseline (pre-infusion) at 30 minutes, 1 week, and 1 month post-treatment:\n\n(30 minutes post-treatment value - BL pre-infusion value)\n\n(1 week post-treatment value - BL pre-infusion value)\n\n(1 month post-treatment value - BL pre-infusion value)"}, {'measure': 'Change in Brief Pain Inventory (BPI): Pain on Average', 'timeFrame': '1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)', 'description': 'The Pain on Average score in the Brief Pain Inventory is rated from 0-10, where 0 is no pain, and 10 is pain as bad as you can imagine.\n\nChange scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:\n\n(1 day post-treatment value - BL pre-infusion value)\n\n(1 week post-treatment value - BL pre-infusion value)\n\n(1 month post-treatment value - BL pre-infusion value)'}, {'measure': 'Change in Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)', 'description': 'The Hospital Anxiety and Depression Scale (HADS) consists of 14 items rated from 0-3 and 2 subscales Depression (7 items) and Anxiety (7 items). A higher score on each item represents more of each symptom (i.e., more depression or more anxiety). Each subscale score is the sum of the 7 items from each subscale.\n\nA score of 0-7 = Normal, 8-10=Borderline abnormal (borderline case), and 11-21=Abnormal (case).\n\nChange scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:\n\n(1 day post-treatment value - BL pre-infusion value)\n\n(1 week post-treatment value - BL pre-infusion value)\n\n(1 month post-treatment value - BL pre-infusion value)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endometriosis', 'chronic pain', 'intravenous lidocaine'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'We are doing this research study to find out if intravenous (in your vein, "IV") lidocaine can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved intravenous lidocaine to treat irregular heart beats, but the FDA has not approved intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used for more than 25 years to treat different acute and chronic pain conditions but has not yet been studied for endometriosis pain.\n\nThis is a cross-over trial over two months where one month you will receive the active medication (lidocaine) and one month you will receive the active placebo (diphenhydramine, commonly known as benadryl). We will compare the effect on pain from endometriosis of lidocaine to active placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Reproductive age women ages 18 - 50\n* Endometriosis diagnosed laparoscopically or by primary care physician or gynecologist using clinical criteria\n* Pain for \\> 6 months\n* Pain most intense around time of menstrual cycle. Pain at least 5 on a 0-10 scale.\n* Receiving regular monthly menses (cannot be receiving Depo-provera injections)\n\nExclusion criteria:\n\n* Pregnant or breastfeeding\n* On lupron therapy\n* History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart block in the absence of a pacemaker\n* History of seizure disorder\n* Significant anxiety, psychosis or other cognitive disorder limiting completion of study procedures\n* History of alcohol or substance abuse\n* Chronic pain symptoms other than chronic pelvic pain (excluding migraine pain)\n* Known hypersensitivity to amide type anesthetics\n* Known hypersensitivity to diphenhydramine (benadryl)\n* History of treatment with lidocaine or mexiletene\n* Having or showing signs and symptoms of liver disease'}, 'identificationModule': {'nctId': 'NCT01968694', 'briefTitle': 'Effects of Intravenous Lidocaine on Endometriosis Pain', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Effects of Intravenous Lidocaine on Endometriosis Pain', 'orgStudyIdInfo': {'id': '2010P002903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Lidocaine', 'description': 'IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes', 'interventionNames': ['Drug: IV Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'IV diphenhydramine', 'description': 'IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes', 'interventionNames': ['Drug: IV diphenhydramine']}], 'interventions': [{'name': 'IV Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['IV Lidocaine']}, {'name': 'IV diphenhydramine', 'type': 'DRUG', 'armGroupLabels': ['IV diphenhydramine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02467', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital Pain Management Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Antje Barreveld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital, Newton-Wellesley Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Antje Barreveld, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}