Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-17 @ 10:25 PM
Study NCT ID:
NCT01983020
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2013-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rkaplan@chpnet.org', 'title': 'Ronald Kaplan, MD', 'organization': 'Beth Israel Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ketamine', 'description': 'Ketamine infused at 0.25 mg/kg/hour.\n\nKetamine', 'otherNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Lidocaine', 'description': 'Lidocaine infused at 0.5 mg/kg/hour.\n\nLidocaine', 'otherNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ketamine and Lidocaine', 'description': 'Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour\n\nLidocaine\n\nKetamine', 'otherNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo (saline) given to compare usual treatment against active agents in post operative pain management.', 'otherNumAtRisk': 11, 'otherNumAffected': 6, 'seriousNumAtRisk': 11, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': 'Ketamine infused at 0.25 mg/kg/hour.\n\nKetamine'}, {'id': 'OG001', 'title': 'Lidocaine', 'description': 'Lidocaine infused at 0.5 mg/kg/hour.\n\nLidocaine'}, {'id': 'OG002', 'title': 'Ketamine and Lidocaine', 'description': 'Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour\n\nLidocaine\n\nKetamine'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo (saline) given to compare usual treatment against active agents in post operative pain management.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.29', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '5.76', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '5.51', 'spread': '2.60', 'groupId': 'OG002'}, {'value': '6.40', 'spread': '2.59', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'postoperative day 1 - 3', 'description': 'The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine', 'description': 'Ketamine infused at 0.25 mg/kg/hour.\n\nKetamine'}, {'id': 'FG001', 'title': 'Lidocaine', 'description': 'Lidocaine infused at 0.5 mg/kg/hour.\n\nLidocaine'}, {'id': 'FG002', 'title': 'Ketamine and Lidocaine', 'description': 'Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour\n\nLidocaine\n\nKetamine'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo (saline) given to compare usual treatment against active agents in post operative pain management.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine', 'description': 'Ketamine infused at 0.25 mg/kg/hour.\n\nKetamine'}, {'id': 'BG001', 'title': 'Lidocaine', 'description': 'Lidocaine infused at 0.5 mg/kg/hour.\n\nLidocaine'}, {'id': 'BG002', 'title': 'Ketamine and Lidocaine', 'description': 'Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour\n\nLidocaine\n\nKetamine'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo (saline) given to compare usual treatment against active agents in post operative pain management.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.8', 'spread': '11.85', 'groupId': 'BG000'}, {'value': '55.16', 'spread': '16.23', 'groupId': 'BG001'}, {'value': '50.3', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '56.3', 'spread': '12.7', 'groupId': 'BG003'}, {'value': '54.39', 'spread': '13.08', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2013-11-07', 'resultsFirstSubmitDate': '2014-08-18', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-28', 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'postoperative day 1 - 3', 'description': 'The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale and Female \\>/= 18 years of age Patients undergoing first-time fusion surgery or surgery to revise a prior fusion Able to read, write and speak in English, and able to give informed consent for the study\n\nExclusion Criteria:\n\nAny disease associated with major organ dysfunction renal dysfunction hepatic dysfunction cardiac dysfunction'}, 'identificationModule': {'nctId': 'NCT01983020', 'briefTitle': 'Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Medical Center'}, 'officialTitle': 'Randomized Double Blind Comparison of Peri-Operative Standard Analgesia With Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery', 'orgStudyIdInfo': {'id': 'IRB 073-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'description': 'Ketamine infused at 0.25 mg/kg/hour.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'Lidocaine infused at 0.5 mg/kg/hour.', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine and Lidocaine', 'description': 'Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour', 'interventionNames': ['Drug: Lidocaine', 'Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (saline) given to compare usual treatment against active agents in post operative pain management.', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Ketamine and Lidocaine', 'Lidocaine']}, {'name': 'Ketamine', 'type': 'DRUG', 'armGroupLabels': ['Ketamine', 'Ketamine and Lidocaine']}, {'name': 'Saline', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ronald Kaplan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}