Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-21 @ 7:52 PM
Study NCT ID:
NCT03057704
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Techniques of IV Lidocaine on Propofol Injection 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D014111', 'term': 'Tourniquets'}], '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': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tharwood@wakehealth.edu', 'phone': '3367164498', 'title': 'Timothy N. Harwood MD', 'organization': 'Wake Forest University School of Medcine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Results became clear at total number of subject =25.'}}, 'adverseEventsModule': {'timeFrame': 'We studied the subjects in this time frame: 1) Initiated contact with them in the holding area just prior to their procedure. 2) We assessed their verbal expression of discomfort and their display of discomfort (outcomes 1 and 2) during propofol injection and up to 30 seconds after injection 3) We assessed their recall of discomfort approximately 30 minutes after their procedure while they were in the recovery area. 4) They were then discharged home without further involvement in the trial.', 'description': 'Patients were interviewed in the recovery room at least 30 minutes after their procedure by one of the investigators, and they were called the next business day by a recovery room nurse for followup and asked about any adverse events they experienced after discharge.', 'eventGroups': [{'id': 'EG000', 'title': 'Intravenous Lidocaine: Flushed', 'description': 'Lidocaine injection flushed\n\nLidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intravenous Lidocaine: Tourniquet', 'description': 'Lidocaine injection tourniquet\n\nLidocaine injection tourniquet: Intravenous lidocaine: tourniquet', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Expression of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine: Flushed', 'description': 'Lidocaine injection flushed\n\nLidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.'}, {'id': 'OG001', 'title': 'Intravenous Lidocaine: Tourniquet', 'description': 'Lidocaine injection tourniquet\n\nLidocaine injection tourniquet: Intravenous lidocaine: tourniquet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During injection at beginning of study; lasts 10 seconds one time only', 'description': "Patient's verbal rating of pain during injection (see link to study protocol)\n\nWe used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:\n\nHow would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:\n\n* None (0)\n* Mild (1)\n* Moderate (2)\n* Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Subject's Recall of Injection Discomfort", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine: Flushed', 'description': 'Lidocaine injection flushed\n\nLidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.'}, {'id': 'OG001', 'title': 'Intravenous Lidocaine: Tourniquet', 'description': 'Lidocaine injection tourniquet\n\nLidocaine injection tourniquet: Intravenous lidocaine: tourniquet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only", 'description': "Investigator asks patient if they recall discomfort during injection after the procedure.\n\nPatient's verbal rating and recall of pain during injection.\n\nWe used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:\n\nHow would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:\n\n* None (0)\n* Mild (1)\n* Moderate (2)\n* Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Investigators Rating of Patient Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Lidocaine: Flushed', 'description': 'Lidocaine injection flushed\n\nLidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.'}, {'id': 'OG001', 'title': 'Intravenous Lidocaine: Tourniquet', 'description': 'Lidocaine injection tourniquet\n\nLidocaine injection tourniquet: Intravenous lidocaine: tourniquet'}], 'classes': [{'categories': [{'measurements': [{'value': '1.12', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During injection at beginning of study period; lasts 10 seconds one time only', 'description': 'Investigator rates patient\'s nonverbal display of discomfort.\n\nInvestigator Assessments:\n\nInduction Discomfort Scale (during injection and within 5 seconds after injection)\n\n* No change in patient behavior (0)\n* Grimace (1)\n* IV forearm withdrawal (2)\n* Moaning (3)\n* Verbal statement of discomfort ("it hurts", etc.) (4) 0 indicates desired outcome of no pain and 4 indicates worst IV pain experienced.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intravenous Lidocaine: Flushed', 'description': 'Lidocaine injection flushed\n\nLidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.'}, {'id': 'FG001', 'title': 'Intravenous Lidocaine: Tourniquet', 'description': 'Lidocaine injection tourniquet\n\nLidocaine injection tourniquet: Intravenous lidocaine: tourniquet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were approached after they were scheduled for colonoscopy or minor procedures and appeared in the holding area for procedures in which propofol sedation or induction of general anesthesia was used.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intravenous Lidocaine: Flushed', 'description': 'Lidocaine injection flushed\n\nLidocaine injection flushed: The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.'}, {'id': 'BG001', 'title': 'Intravenous Lidocaine: Tourniquet', 'description': 'Lidocaine injection tourniquet\n\nLidocaine injection tourniquet: Intravenous lidocaine: tourniquet'}, {'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': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '54', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '53', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain score at IV prior to procedure', 'classes': [{'categories': [{'title': 'IV pain score of 0', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'IV pain score of 1-3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects were eligible is schedule for procedures in which they would receive propofol for sedation or induction. Subjects included a general local population from the Piedmont Triad of North Carolina.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-30', 'size': 885143, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2017-11-06T15:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The participant is not told which group they are randomized to. However, a tourniquet is applied in the experimental group, thus some subjects may reason that they are in the experimental group. The study coordinator is aware which group the subject is in.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, controlled trial of two methods of administering lidocaine prior to propofol injection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2017-02-15', 'resultsFirstSubmitDate': '2017-11-13', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-16', 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Expression of Pain', 'timeFrame': 'During injection at beginning of study; lasts 10 seconds one time only', 'description': "Patient's verbal rating of pain during injection (see link to study protocol)\n\nWe used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:\n\nHow would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:\n\n* None (0)\n* Mild (1)\n* Moderate (2)\n* Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome)."}], 'secondaryOutcomes': [{'measure': "Subject's Recall of Injection Discomfort", 'timeFrame': "This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only", 'description': "Investigator asks patient if they recall discomfort during injection after the procedure.\n\nPatient's verbal rating and recall of pain during injection.\n\nWe used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:\n\nHow would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:\n\n* None (0)\n* Mild (1)\n* Moderate (2)\n* Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome)."}, {'measure': 'Investigators Rating of Patient Discomfort', 'timeFrame': 'During injection at beginning of study period; lasts 10 seconds one time only', 'description': 'Investigator rates patient\'s nonverbal display of discomfort.\n\nInvestigator Assessments:\n\nInduction Discomfort Scale (during injection and within 5 seconds after injection)\n\n* No change in patient behavior (0)\n* Grimace (1)\n* IV forearm withdrawal (2)\n* Moaning (3)\n* Verbal statement of discomfort ("it hurts", etc.) (4) 0 indicates desired outcome of no pain and 4 indicates worst IV pain experienced.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Propofol', 'lidocaine', 'pain'], 'conditions': ['Injections, Intravenous']}, 'descriptionModule': {'briefSummary': 'Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection of propofol to reduce the amount of pain during propofol injection. The investigators want to study if giving the lidocaine through the IV while the forearm on the same limb has a tourniquet applied to it to prevent "washing out" of the lidocaine prior to propofol injection helps reduce propofol injection pain.', 'detailedDescription': 'The investigators expect that tourniquet lidocaine is superior to straight non-tourniquet lidocaine in reducing propofol injection pain. The investigators also wanted to determine the association of tourniquet duration on reduction of pain with propofol administration. Small studies indicate that 60 seconds of tourniquet lidocaine is superior to 30 seconds or less of tourniquet duration or mixed lidocaine/propofol for injection. The investigators suspect many clinicians do not use the 60-second tourniquet technique due to the extra time involved but hypothesize that a more practical application by applying the tourniquet as soon as the patient is positioned on the operating table will not only be more widely adopted by clinicians as it does not cause delay but also provide the necessary amount of time for benefit from the tourniquet. The investigators also wanted to record the time from tourniquet application to start of propofol administration, which the investigators predict would be at least 60 seconds to see if there is a correlation between duration of venous stasis of IV lidocaine and pain benefit.\n\nMethods and Measures\n\nDesign This was conducted as a randomized controlled trial of two methods of administering lidocaine prior to propofol injection.\n\nSetting The study setting was located within North Carolina Baptist Health, an academic medical center, in the Endoscopy Suite or Outpatient Surgery Center where subjects were scheduled to receive propofol as part of their sedation or anesthetic.\n\nSample Size The investigators estimated that 25 subjects in each of the two groups was required to test the hypothesis based on prior studies.\n\nInterventions and Interactions\n\nThe investigators used two groups:\n\n* Group 1: 50mg of 2% lidocaine given just prior to the propofol dose through the IV line.\n* Group 2: 50mg of 2% lidocaine given IV with venous occlusion applied when the patient is positioned on the operating room table and timed until the onset of propofol administration. The tourniquet the investigators used was a Quick Release tourniquet applied to the forearm 10cm distal to the elbow joint in the tourniquet group. Venous stasis was confirmed with cessation of flow from hanging IV fluid.\n\nFor both groups, no premedication was given, which is the normal practice for these procedures. Study procedures involved placing a 20 gauge intravenous (IV) catheter in a vein distal to the mid forearm. Venous occlusion was achieved by either a latex free tourniquet or McKesson Quick Release tourniquet applied to the forearm 10cm distal to the elbow joint. Tourniquet pressure was somewhat variable but sufficient to cause venous stasis as confirmed by no flow of hanging IV fluid. Injections were delivered at roughly 1 ml/sec.\n\nSchedule of events in the study (all performed by 1 of the 2 investigators:\n\n* Day of procedure: holding area\n\n * Consent subject for study participation\n * Randomly assign patient to one of two groups\n* Day of procedure: procedure area\n\n -Accompany subject to the operating or procedure room, perform protocol from the group to which the subjects were assigned, while noting outcome measures such as self-described discomfort and observer graded discomfort\n* Day of procedure: recovery area\n\n -Revisit subject in recovery 30 minutes after their procedure to determine post-procedure recall of discomfort\n* Post-study period\n* Analyze data\n\nAnalytical Plan The investigators will analyze results initially using descriptive statistics. Comparison between groups was done using chi square tests for proportions, and t-tests or ANOVA procedures for continuous variables. Regression analysis was performed to identify independent outcome predictors. Other inferential statistical analysis was conducted as appropriate.\n\nInformed Consent One of the two investigators obtained signed informed consent from each subject. This was performed in the holding room prior to the procedure since most subjects had their pre-procedure examination performed in the holding room and were not seen prior to the day of their procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any subject at North Carolina Baptist Hospital scheduled for a procedure in which they will receive propofol for sedation or anesthesia and will not be receiving any other medications prior to the propofol injection.\n* Cases must be schedule to have a duration less than 60 minutes.\n\nExclusion Criteria:\n\n* Subjects are excluded if they cannot verbalize a rating of pain\n* Subjects are excluded if they require intravenous medications prior to the study period'}, 'identificationModule': {'nctId': 'NCT03057704', 'briefTitle': 'Comparison of Two Techniques of IV Lidocaine on Propofol Injection Pain', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Comparison of Two Techniques of Administering IV Lidocaine in Reducing Propofol Injection Pain', 'orgStudyIdInfo': {'id': 'IRB00040756'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous lidocaine: flushed', 'description': 'Lidocaine injection flushed', 'interventionNames': ['Drug: Lidocaine injection flushed']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous lidocaine: tourniquet', 'description': 'Lidocaine injection tourniquet', 'interventionNames': ['Drug: Lidocaine injection tourniquet']}], 'interventions': [{'name': 'Lidocaine injection flushed', 'type': 'DRUG', 'otherNames': ['Xylocaine'], 'description': 'The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.', 'armGroupLabels': ['Intravenous lidocaine: flushed']}, {'name': 'Lidocaine injection tourniquet', 'type': 'DRUG', 'otherNames': ['Xylocaine', 'Tourniquet'], 'description': 'Intravenous lidocaine: tourniquet', 'armGroupLabels': ['Intravenous lidocaine: tourniquet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27612', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Baptist Hospital', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Timothy N Harwood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}, {'name': 'Patrick Grace, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}