Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT01701102
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2012-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008619', 'term': 'Mepivacaine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chengj@hss.edu', 'phone': '212-774-7377', 'title': 'Jennifer Cheng', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mepivacaine 37.5 mg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mepivacaine 30 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Mepivacaine 27 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Mepivacaine 24 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mepivacaine 37.5 mg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)'}, {'id': 'OG001', 'title': 'Mepivacaine 30 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)'}, {'id': 'OG002', 'title': 'Mepivacaine 27 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)'}, {'id': 'OG003', 'title': 'Mepivacaine 24 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)'}], 'classes': [{'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000', 'lowerLimit': '165', 'upperLimit': '231'}, {'value': '195', 'groupId': 'OG001', 'lowerLimit': '175', 'upperLimit': '210'}, {'value': '156', 'groupId': 'OG002', 'lowerLimit': '135', 'upperLimit': '180'}, {'value': '159', 'groupId': 'OG003', 'lowerLimit': '135', 'upperLimit': '194'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.', 'description': 'The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mepivacaine 37.5 mg', 'description': 'Mepivacaine (37.5 mg)'}, {'id': 'FG001', 'title': 'Mepivacaine 30 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (30 mg) and fentanyl (10 µg)'}, {'id': 'FG002', 'title': 'Mepivacaine 27 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (27 mg) and fentanyl (10 µg)'}, {'id': 'FG003', 'title': 'Mepivacaine 24 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 mg) and fentanyl (10 µg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'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': '22', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Mepivacaine 37.5 mg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)'}, {'id': 'BG001', 'title': 'Mepivacaine 30 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)'}, {'id': 'BG002', 'title': 'Mepivacaine 27 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)'}, {'id': 'BG003', 'title': 'Mepivacaine 24 mg Plus Fentanyl 10 µg', 'description': 'Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '55'}, {'value': '50', 'groupId': 'BG001', 'lowerLimit': '42', 'upperLimit': '57'}, {'value': '46', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '60'}, {'value': '45', 'groupId': 'BG003', 'lowerLimit': '19', 'upperLimit': '60'}, {'value': '44', 'groupId': 'BG004', 'lowerLimit': '19', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '26.0', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '28.5', 'spread': '5.6', 'groupId': 'BG002'}, {'value': '28.7', 'spread': '4.8', 'groupId': 'BG003'}, {'value': '27.4', 'spread': '4.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/(m^2)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-09', 'studyFirstSubmitDate': '2012-01-04', 'resultsFirstSubmitDate': '2016-02-11', 'studyFirstSubmitQcDate': '2012-10-03', 'lastUpdatePostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-11', 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)', 'timeFrame': 'Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.', 'description': 'The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthroscopic Knee Surgery']}, 'descriptionModule': {'briefSummary': 'Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 18-60\n* Patients scheduled for "simple" knee arthroscopies, including meniscectomy, debridement, and plica.\n\nExclusion Criteria:\n\n* Subjects aged \\<18 or \\>60\n* Subjects greater than 190 cm in height\n* Patients scheduled for ligament reconstruction or surgery involving bone\n* Daily use of narcotics for greater than one week pre-op'}, 'identificationModule': {'nctId': 'NCT01701102', 'briefTitle': 'Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy', 'orgStudyIdInfo': {'id': '11140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mepivacaine 37.5 mg', 'interventionNames': ['Procedure: Mepivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mepivacaine 30 mg plus fentanyl 10 µg', 'interventionNames': ['Procedure: Mepivacaine (30 mg) plus fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mepivacaine 27 mg plus fentanyl 10 µg', 'interventionNames': ['Procedure: Mepivacaine (27 mg) plus fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mepivacaine 24 mg plus fentanyl 10 µg', 'interventionNames': ['Procedure: Mepivacaine (24 mg) plus fentanyl']}], 'interventions': [{'name': 'Mepivacaine (24 mg) plus fentanyl', 'type': 'PROCEDURE', 'description': 'Mepivacaine (24 mg) and fentanyl (10 µg)', 'armGroupLabels': ['Mepivacaine 24 mg plus fentanyl 10 µg']}, {'name': 'Mepivacaine (27 mg) plus fentanyl', 'type': 'PROCEDURE', 'description': 'Mepivacaine (27 mg) and fentanyl (10 µg)', 'armGroupLabels': ['Mepivacaine 27 mg plus fentanyl 10 µg']}, {'name': 'Mepivacaine (30 mg) plus fentanyl', 'type': 'PROCEDURE', 'description': 'Mepivacaine (30 mg) and fentanyl (10 µg)', 'armGroupLabels': ['Mepivacaine 30 mg plus fentanyl 10 µg']}, {'name': 'Mepivacaine', 'type': 'PROCEDURE', 'description': 'Mepivacaine 37.5 mg', 'armGroupLabels': ['Mepivacaine 37.5 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}