Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-07 @ 7:58 PM
Study NCT ID:
NCT03182933
Status:
TERMINATED
Last Update Posted:
2019-06-25
First Post:
2017-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lzitur@wisc.edu', 'phone': '6082638118', 'title': 'Laura Zitur - research program manager', 'organization': 'University of Wisconsin'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 72 hours', 'description': 'Any events that were deemed to be reportable events were discussed with the IRB', 'eventGroups': [{'id': 'EG000', 'title': 'Liposomal Bupivacaine Group', 'description': '20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 1, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Bupivacaine Group', 'description': '20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Falls', 'notes': 'Fall as a result of prolonged quadriceps weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Fall'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '10 Meter Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine Group', 'description': '20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}, {'id': 'OG001', 'title': 'Standard Bupivacaine Group', 'description': '20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Time to comfortably walk 10 meters as deemed safe by physical therapy', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine Group', 'description': '20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}, {'id': 'OG001', 'title': 'Standard Bupivacaine Group', 'description': '20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '4.9', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, Day 1, Day 2, Day 3', 'description': 'Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Consumption in Morphine Equivalents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine Group', 'description': '20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}, {'id': 'OG001', 'title': 'Standard Bupivacaine Group', 'description': '20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}], 'classes': [{'title': 'Day 0 (OR)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 0 (PACU)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '51.2', 'spread': '29.2', 'groupId': 'OG000'}, {'value': '66.1', 'spread': '36.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '39.5', 'spread': '28.6', 'groupId': 'OG000'}, {'value': '54.8', 'spread': '37.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '25.8', 'spread': '33.0', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '20.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3', 'description': 'Total opioid consumption will be measured in all patients over the course of 3 days and converted to oral morphine equivalents so that it can be statistically compared.', 'unitOfMeasure': 'Morphine equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine Group', 'description': '20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}, {'id': 'OG001', 'title': 'Standard Bupivacaine Group', 'description': '20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}], 'classes': [{'title': 'Day 0 (PACU)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0, Day 1, Day 2, Day 3', 'description': 'Post operative nausea and vomiting as documented in the PACU and volunteered in an over the phone interview', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quadriceps Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine Group', 'description': '20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}, {'id': 'OG001', 'title': 'Standard Bupivacaine Group', 'description': '20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '11', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '12.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Quadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected.', 'unitOfMeasure': 'Pounds of Force', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liposomal Bupivacaine Group', 'description': '20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}, {'id': 'FG001', 'title': 'Standard Bupivacaine Group', 'description': '20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Study aimed to obtain 70 patients to account for dropout, however was sufficiently powered if 60 patients enrolled. Study was terminated after 64th patient due to surgeon preferences.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liposomal Bupivacaine Group', 'description': '20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}, {'id': 'BG001', 'title': 'Standard Bupivacaine Group', 'description': '20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)\n\nPeripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization\n\n10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist\n\nIn person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores\n\nForce transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.6', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '64.8', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '65.8', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-07', 'size': 339950, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-07T14:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'Terminated due to surgeon preferences', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2017-06-01', 'resultsFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-05', 'studyFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10 Meter Walk Test', 'timeFrame': '24 hours', 'description': 'Time to comfortably walk 10 meters as deemed safe by physical therapy'}], 'secondaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': 'Day 0, Day 1, Day 2, Day 3', 'description': 'Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain.'}, {'measure': 'Opioid Consumption in Morphine Equivalents', 'timeFrame': 'Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3', 'description': 'Total opioid consumption will be measured in all patients over the course of 3 days and converted to oral morphine equivalents so that it can be statistically compared.'}, {'measure': 'Number of Participants Who Experienced Nausea', 'timeFrame': 'Day 0, Day 1, Day 2, Day 3', 'description': 'Post operative nausea and vomiting as documented in the PACU and volunteered in an over the phone interview'}, {'measure': 'Quadriceps Strength', 'timeFrame': '24 hours', 'description': 'Quadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['10 meter walk test', 'Opioid consumption'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on physical therapy measures and pain scores as well as opiate consumption.', 'detailedDescription': 'Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain. This pain can oftentimes be severe enough to limit participation in physical therapy and ultimately delay discharge resulting in increased cost. Several strategies have been developed in an effort to decrease postoperative pain following TKA while maintaining lower extremity strength and maximizing participation in physical therapy. Recently, adductor canal blockade has gained popularity as it is reported to provide analgesia to the anterior knee without resulting in significant quadriceps muscle weakness. One downside of single shot peripheral blockade is the duration of analgesia can oftentimes be short lived. The advent of depot local anesthetics has made this an attractive option, especially in busy practices where placing peri-neural catheters may not be practical or cost effective. This study aims to carefully evaluate this relationship using a physical therapy evaluation method that relies on both motor strength and pain control. In addition, we hope to carefully evaluate motor strength using a novel method of strength measurement in an effort to further evaluate the impact of depot local anesthetic injection into the adductor canal on physical therapy and analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject is scheduled for elective unilateral TKA;\n2. The subject is ≥ 18 years and ≤ 80 years;\n3. The subject's weight is between 65-130 kg;\n4. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural);\n5. The patient agrees to receive an adductor canal block;\n6. American Society of Anesthesiologists class 1-3.\n\nExclusion Criteria:\n\n1. Subject is \\< 18 years of age or \\>80 years of age;\n2. Subject is non-English speaking;\n3. Subject is known or believed to be pregnant;\n4. Subject is a prisoner;\n5. Subject has impaired decision-making capacity per discretion of the Investigator;\n6. Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration;\n7. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate;\n8. Significant pre-existing neuropathy on the operative limb;\n9. Significant renal, cardiac or hepatic disease per discretion of the investigator;\n10. American Society of Anesthesiologists class 4-5;\n11. Known hypersensitivity and/or allergies to local anesthetics;\n12. Chronic Opioid Use (daily or almost daily use of opioids for \\> 3 months)."}, 'identificationModule': {'nctId': 'NCT03182933', 'briefTitle': 'Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Impact of Liposomal Bupivacaine Injected for Adductor Canal Block on Recovery Profile and Block Characteristics Following Total Knee Arthroplasty.', 'orgStudyIdInfo': {'id': '2016-0869'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liposomal bupivacaine group', 'description': '20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)', 'interventionNames': ['Drug: Peripheral Nerve Blockade', 'Behavioral: 10 meter walk test on post-operative day 1', 'Other: In person and over the phone questionnaire', 'Device: Force transduction of quadriceps strength']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard bupivacaine group', 'description': '20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)', 'interventionNames': ['Drug: Peripheral Nerve Blockade', 'Behavioral: 10 meter walk test on post-operative day 1', 'Other: In person and over the phone questionnaire', 'Device: Force transduction of quadriceps strength']}], 'interventions': [{'name': 'Peripheral Nerve Blockade', 'type': 'DRUG', 'description': 'Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization', 'armGroupLabels': ['Liposomal bupivacaine group', 'Standard bupivacaine group']}, {'name': '10 meter walk test on post-operative day 1', 'type': 'BEHAVIORAL', 'description': 'Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist', 'armGroupLabels': ['Liposomal bupivacaine group', 'Standard bupivacaine group']}, {'name': 'In person and over the phone questionnaire', 'type': 'OTHER', 'description': 'Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores', 'armGroupLabels': ['Liposomal bupivacaine group', 'Standard bupivacaine group']}, {'name': 'Force transduction of quadriceps strength', 'type': 'DEVICE', 'description': 'Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1', 'armGroupLabels': ['Liposomal bupivacaine group', 'Standard bupivacaine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53718', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The American Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}