Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT02499159
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pain Management in Response to Exparel vs. Standard Bupivicaine
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': 'Devon.Collins@inova.org', 'phone': '703-776-4096', 'title': 'Devon Collins', 'organization': 'Inova Health System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.', 'eventGroups': [{'id': 'EG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.", 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 5, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Amaurosis Fugax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nose bleeds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary blockage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Occipital Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Amounts of Pain Medications Consumed Through Post-operative Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'OG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1294', 'groupId': 'OG000'}, {'value': '1455.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed daily for 7 days post-procedure', 'description': 'Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets.', 'unitOfMeasure': 'tablets', 'reportingStatus': 'POSTED', 'populationDescription': '4 participants from the Exparel group and 6 participants from the standard group did not return a questionnaire.'}, {'type': 'SECONDARY', 'title': 'Scores on a Analog Pain Scale (7 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'OG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed at day 7 post-procedure', 'description': 'Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.', 'unitOfMeasure': 'Median score on postoperative day 7', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Scores on an Analog Pain Scale (30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'OG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed at 30 days post-procedure', 'description': 'Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.', 'unitOfMeasure': 'Median score on postoperative day 30', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '42 subjects in the Exparel group and 47 subjects in the standard group completed the 30-day survey.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Paresthesias (Postoperatively at 7 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'OG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at day 7 post-procedure', 'description': 'Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Paresthesias (Postoperatively at 30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'OG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at day 30 post-procedure', 'description': 'Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '42 subjects in the Exparel group and 47 subjects in the standard group completed the 30-day survey.'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'OG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From end of procedure until discharge, usually 0-2 days.', 'description': 'Median length of stay in days until discharge.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Return to Baseline Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'OG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 30 days post-procedure', 'description': 'Using surveys, patients are asked if they have been able to return to baseline activity levels.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '42 subjects in the Exparel group and 47 subjects in the standard group completed the 30 day survey.'}, {'type': 'SECONDARY', 'title': 'Return to Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'OG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 30 days post-procedure', 'description': 'Using surveys, patients are asked if they have been able to return to work.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '42 subjects in the Exparel group and 47 patients in the standard group completed the 30-day survey.'}, {'type': 'SECONDARY', 'title': 'Days Until Return to Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'OG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed at 30 days post-procedure', 'description': 'Using surveys, the number of days to return to work was assessed for patients who were able to return to work.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'At the 30-day call, 24 subjects in the Exparel group and 17 subjects in the standard group indicated that they were able to return to work. Number of days were assessed for these subjects.'}, {'type': 'SECONDARY', 'title': 'Overall Hospital Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'OG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'timeFrame': 'Total cost assessed from patient registration until discharge to home (usually 0-2 days).', 'description': 'Overall hospital cost of patient procedure and stay will be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on hospital cost was not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'FG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}], 'periods': [{'title': 'Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '30-Day Follow-Up Phone Call', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal due to ineligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\nLiposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle."}, {'id': 'BG001', 'title': '0.25% Standard Bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.\n\n0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '65', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '64', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '77', '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': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Two patients who were enrolled were not randomized due to screen failing after consent. These two patients are not included in the baseline population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-26', 'size': 244904, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-24T15:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2015-07-08', 'resultsFirstSubmitDate': '2019-08-13', 'studyFirstSubmitQcDate': '2015-07-13', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-13', 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Amounts of Pain Medications Consumed Through Post-operative Day 7', 'timeFrame': 'Assessed daily for 7 days post-procedure', 'description': 'Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets.'}], 'secondaryOutcomes': [{'measure': 'Scores on a Analog Pain Scale (7 Days)', 'timeFrame': 'Assessed at day 7 post-procedure', 'description': 'Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.'}, {'measure': 'Scores on an Analog Pain Scale (30 Days)', 'timeFrame': 'Assessed at 30 days post-procedure', 'description': 'Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.'}, {'measure': 'Number of Patients With Paresthesias (Postoperatively at 7 Days)', 'timeFrame': 'Assessed at day 7 post-procedure', 'description': 'Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure.'}, {'measure': 'Proportion of Patients With Paresthesias (Postoperatively at 30 Days)', 'timeFrame': 'Assessed at day 30 post-procedure', 'description': 'Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'From end of procedure until discharge, usually 0-2 days.', 'description': 'Median length of stay in days until discharge.'}, {'measure': 'Return to Baseline Activity', 'timeFrame': 'Assessed at 30 days post-procedure', 'description': 'Using surveys, patients are asked if they have been able to return to baseline activity levels.'}, {'measure': 'Return to Work', 'timeFrame': 'Assessed at 30 days post-procedure', 'description': 'Using surveys, patients are asked if they have been able to return to work.'}, {'measure': 'Days Until Return to Work', 'timeFrame': 'Assessed at 30 days post-procedure', 'description': 'Using surveys, the number of days to return to work was assessed for patients who were able to return to work.'}, {'measure': 'Overall Hospital Cost', 'timeFrame': 'Total cost assessed from patient registration until discharge to home (usually 0-2 days).', 'description': 'Overall hospital cost of patient procedure and stay will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exparel', 'Thoracoscopy', 'Bupivicaine', 'Liposomal'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '19022040', 'type': 'BACKGROUND', 'citation': 'Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009.'}, {'pmid': '19699918', 'type': 'BACKGROUND', 'citation': 'Allen MS, Halgren L, Nichols FC 3rd, Cassivi SD, Harmsen WS, Wigle DA, Shen KR, Deschamps C. A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. Ann Thorac Surg. 2009 Sep;88(3):903-10. doi: 10.1016/j.athoracsur.2009.04.139.'}, {'pmid': '1914056', 'type': 'BACKGROUND', 'citation': 'Chan VW, Chung F, Cheng DC, Seyone C, Chung A, Kirby TJ. Analgesic and pulmonary effects of continuous intercostal nerve block following thoracotomy. Can J Anaesth. 1991 Sep;38(6):733-9. doi: 10.1007/BF03008451.'}, {'pmid': '12969101', 'type': 'BACKGROUND', 'citation': 'Debreceni G, Molnar Z, Szelig L, Molnar TF. Continuous epidural or intercostal analgesia following thoracotomy: a prospective randomized double-blind clinical trial. Acta Anaesthesiol Scand. 2003 Oct;47(9):1091-5. doi: 10.1034/j.1399-6576.2003.00208.x.'}, {'pmid': '9725371', 'type': 'BACKGROUND', 'citation': 'Kaiser AM, Zollinger A, De Lorenzi D, Largiader F, Weder W. Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain. Ann Thorac Surg. 1998 Aug;66(2):367-72. doi: 10.1016/s0003-4975(98)00448-2.'}, {'pmid': '15166580', 'type': 'BACKGROUND', 'citation': 'American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2004 Jun;100(6):1573-81. doi: 10.1097/00000542-200406000-00033. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications.\n\nPatients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.', 'detailedDescription': "Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection.\n\nIt is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine.\n\nPatients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space.\n\nPatients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over 18 years of age\n* Isolated thoracoscopic procedure for therapeutic or diagnostic purposes\n\nExclusion Criteria:\n\n* Previous ipsilateral thoracic surgery\n* Need for operative pleurectomy or pleurodesis\n* Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs (NSAIDs), sedatives, or hypnotics\n* Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen\n* Liver dysfunction (INR \\> 1.5, albumin \\< 2.8g/dl, bilirubin \\> 2mg/dl)\n* Renal dysfunction (eGFR \\< 60ml/min/1.73m2)\n* History of peptic ulcerative disease\n* Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen supplementation\n* Inability to consent\n* Pregnancy\n* Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy\n* Patient is discharged from the hospital with a chest tube in place\n* Patient fails to comply with post-operative instructions'}, 'identificationModule': {'nctId': 'NCT02499159', 'acronym': 'VATS Exparel', 'briefTitle': 'Pain Management in Response to Exparel vs. Standard Bupivicaine', 'organization': {'class': 'OTHER', 'fullName': 'Inova Health Care Services'}, 'officialTitle': 'A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy', 'orgStudyIdInfo': {'id': '14-1656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exparel', 'description': "Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.", 'interventionNames': ['Drug: Liposomal Bupivicaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.25% standard bupivicaine', 'description': 'Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.', 'interventionNames': ['Drug: 0.25% standard bupivicaine']}], 'interventions': [{'name': 'Liposomal Bupivicaine', 'type': 'DRUG', 'otherNames': ['Exparel'], 'description': "266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.", 'armGroupLabels': ['Exparel']}, {'name': '0.25% standard bupivicaine', 'type': 'DRUG', 'otherNames': ['Bupivicaine'], 'description': 'standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.', 'armGroupLabels': ['0.25% standard bupivicaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Cardiac, Vascular, and Thoracic Surgery Associates', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}], 'overallOfficials': [{'name': 'Sandeep J Khandhar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiac, Vascular, and Thoracic Surgery Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inova Health Care Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mednax National Medical Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}