Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT01508832
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2012-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'millerr@anesthesia.ucsf.edu', 'phone': '415 476-9034', 'title': 'Ronald D Miller, MD', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine', 'description': 'Lidocaine digital block in right or left finger', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bupivacaine', 'description': 'Bupivacaine digital block right or left finger', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blister', 'notes': '2-3 millimeter raised, reddened blister-like area at the base of both the right and left 4th finger of the same participant. No drainage, pain or irritation noted. Participant was contacted to verify resolution at 7 days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change in the Average Finger Temperature From Baseline to Post-intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine', 'description': 'Lidocaine 1% digital nerve block (2cc) in one finger'}, {'id': 'OG001', 'title': 'Bupivacaine', 'description': 'Bupivacaine 0.25% digital nerve block (2cc) in one finger'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.35', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes prior and 240 minutes post intervention.', 'unitOfMeasure': 'degrees centigrade', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The correspondingly-treated(lidocaine, bupivacaine) finger of all 12 study participants included in analysis for each arm/group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger', 'description': 'Lidocaine 1% digital nerve block (2cc), right finger; Bupivacaine 0.25% digital nerve block (2cc), left finger.'}, {'id': 'FG001', 'title': 'Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger', 'description': 'Lidocaine 1% digital nerve block (2cc), left finger; Bupivacaine 0.25% digital nerve block (2cc), right finger.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Volunteers recruited through local media source. Protocol consisted of a single study day in anesthesia research study space at the University of California San Francisco Parnassus campus.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger', 'description': 'Lidocaine 1% Digital Nerve Block (2 cc) , right finger. Bupivacaine 0.25% Digital Nerve Block (2 cc), left finger'}, {'id': 'BG001', 'title': 'Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger', 'description': 'Lidocaine 1% Digital Block (2cc), left finger; Bupivacaine 0.25% Digital Block (2 cc), right finger.'}, {'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': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', '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': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2012-01-09', 'resultsFirstSubmitDate': '2013-05-23', 'studyFirstSubmitQcDate': '2012-01-11', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-08-16', 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change in the Average Finger Temperature From Baseline to Post-intervention.', 'timeFrame': '30 minutes prior and 240 minutes post intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Onset and Duration of a Digital Nerve Block']}, 'descriptionModule': {'briefSummary': 'The duration of the autonomic (sympathetic) block will last longer than the sensory block. The duration of the increased perfusion index will last longer than either the sympathetic or sensory block.', 'detailedDescription': 'The Masimo SpHb™ (SpHb) is a device used to monitor the blood hemoglobin level via a sticky sensor connected to a finger. Our results from 2 recent studies undertaken with this device concluded: 1) that it is not always accurate when the finger is cold such as during surgical blood loss, and 2) a local nerve block to the finger improved the finger temperature and the accuracy of the device.\n\nOur purpose is to investigate the duration of effect of two local nerve blocking drugs (lidocaine and bupivacaine - both FDA approved drugs in routine use) in a finger on each hand. Having a better understanding of how long the nerve block lasts could help determine when an additional block might be necessary to maintain the accuracy of the device during surgical blood loss.\n\nWe previously listed the primary outcome for this study as the time until return to baseline finger temperature. However, in blinded looks at the data it became clear that defining time until return to baseline from the serial temperature measurements in an objective fashion would be extremely difficult and potentially controversial. We have modified the primary outcome to be the change in the average temperature from baseline to post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smokers\n\nExclusion Criteria:\n\n* History of allergic response to local anesthetics\n* BMI \\>25\n* Pregnant of nursing\n* Current smokers or past smokers of \\> 1 pack year history\n* Neurological deficit and/or injury in the upper extremities\n* Current respiratory infection\n* Per investigator judgement, would not be suitable for study'}, 'identificationModule': {'nctId': 'NCT01508832', 'briefTitle': 'Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers', 'orgStudyIdInfo': {'id': '11-06121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Lidocaine 1% Digital Nerve Block (2 cc)', 'interventionNames': ['Drug: Lidocaine Digital Nerve Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine', 'description': 'Bupivacaine 0.25% Digital Block (2 cc)', 'interventionNames': ['Drug: Bupivacaine Digital Block']}], 'interventions': [{'name': 'Lidocaine Digital Nerve Block', 'type': 'DRUG', 'description': 'Lidocaine 1% Digital Nerve Block (2 cc', 'armGroupLabels': ['Lidocaine']}, {'name': 'Bupivacaine Digital Block', 'type': 'DRUG', 'description': 'Bupivacaine 0.25% Digital Block (2 cc)', 'armGroupLabels': ['Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Ronald Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}