Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
Study NCT ID:
NCT03887650
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2019-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kevin.Finkel@hhchealth.org', 'phone': '860-972-1778', 'title': 'Dr. Kevin Finkel', 'organization': 'Hartford Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Opioid consumption was subjected to patient recall and reporting bias. Patients were advised by surgery clinics to limit opioid intake postoperatively, which might indirectly limit opioid use and made it more difficult to show a difference. The study was double-blinded, the anesthesiologists who performed the block, were unblinded due to the difference in the physical appearance of the study drugs.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected up to 60 postoperative days.', 'eventGroups': [{'id': 'EG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 18, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 21, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash', 'notes': 'Rash around the block site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'notes': 'Swelling of shoulder surgical site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ringing in ears', 'notes': 'On the block side', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness and tingling', 'notes': 'Of same surgery side shoulder and arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'OG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'classes': [{'categories': [{'measurements': [{'value': '71.25', 'groupId': 'OG000', 'lowerLimit': '43.00', 'upperLimit': '120.00'}, {'value': '90.30', 'groupId': 'OG001', 'lowerLimit': '57.37', 'upperLimit': '133.43'}]}]}], 'analyses': [{'pValue': '0.127', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 120 postoperative hours', 'description': 'Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)', 'unitOfMeasure': 'MME', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '3 patients withdrew from Bupivacaine 0.5% with Adjuncts group.'}, {'type': 'SECONDARY', 'title': 'Time to First Opioid Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'OG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5667', 'groupId': 'OG000', 'lowerLimit': '5.800', 'upperLimit': '20.850'}, {'value': '12.025', 'groupId': 'OG001', 'lowerLimit': '4.404', 'upperLimit': '21.983'}]}]}], 'analyses': [{'pValue': '.975', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'from the time of the block injection until discharge, assessed up to 72 postoperative hours.', 'description': 'From block time to the first dose of opioids given, measured in hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data for 2 patients from the Liposomal Bupivacaine 1.3% group. 3 patients withdrew consents from the Bupivacaine 0.5% with Adjuncts group.'}, {'type': 'SECONDARY', 'title': 'Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'OG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'classes': [{'title': 'PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.50'}]}]}, {'title': 'PACU-24 hours Minimum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': 'PACU-24 hours Maximum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '4.50'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '4.50'}]}]}, {'title': 'PACU-24 hours Average', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '3.50'}]}]}, {'title': '24-48 hours Minimum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '3.75'}]}]}, {'title': '24-48 hours Maximum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '7.00', 'groupId': 'OG001', 'lowerLimit': '5.00', 'upperLimit': '8.00'}]}]}, {'title': '24-48 hours Average', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '3.75'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '5.00'}]}]}, {'title': '48-72 hours Minimum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.00'}]}]}, {'title': '48-72 hours Maximum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '6.00'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '4.50', 'upperLimit': '7.00'}]}]}, {'title': '48-72 hours Average', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.25'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '5.00'}]}]}, {'title': '72-96 hours Minimum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '2.00'}]}]}, {'title': '72-96 hours Maximum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '1.75', 'upperLimit': '5.25'}, {'value': '5.00', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '7.0'}]}]}, {'title': '72-96 hours Average', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}, {'title': '60 days postoperative Maximum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '4.25', 'upperLimit': '8.00'}]}]}, {'title': '60 days postoperative Average', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '3.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.00'}]}]}, {'title': '60 days postoperative Minimum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.75'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.00'}]}]}], 'analyses': [{'pValue': '.852', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'PACU pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.661', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (PACU-24) minimum pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.747', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (PACU-24 hr.) maximum pain score', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.604', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (PACU-24 hr) average pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '(24-48 hr) minimum pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (24-48 hr) maximum pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (24-48 hr) average pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.011', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '(48-72 hr) minimum pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '(48-72 hr) maximum pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.003', 'groupIds': ['OG000'], 'pValueComment': '(48-72 hr) average pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.230', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (72-96 hr) minimum pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.007', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (72-96 hr) maximum pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.011', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (72-96 hr) average pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.378', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (postoperative day 60) minimum pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (postoperative day 60) maximum pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.403', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For (postoperative day 60) average pain scores', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60', 'description': 'Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain.', 'unitOfMeasure': 'units on a scale 0-10', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients withdrew consent from the control group (Bupivacaine 0.5% with adjuncts) and one from the liposomal bupivacaine group. The rest is missing data from lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Hospital Length-of-stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'OG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'classes': [{'categories': [{'measurements': [{'value': '31.05', 'groupId': 'OG000', 'lowerLimit': '29.67', 'upperLimit': '32.53'}, {'value': '31.63', 'groupId': 'OG001', 'lowerLimit': '30.63', 'upperLimit': '36.58'}]}]}], 'analyses': [{'pValue': '.112', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of admission until discharge, assessed up to 72 hours.', 'description': 'From the date and time of admission to the date and time of discharge, Measured in hours.', 'unitOfMeasure': 'hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Patient Overall Satisfaction With Pain Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'OG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'classes': [{'title': 'POD4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'title': '10/10', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'below 10', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Missing data', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'POD60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'title': '10/10', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'below 10', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Missing data', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-Value for POD4', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Fisher's Exact for POD4"}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For POD60', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Chi-squared for POD60'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'POD4 - 60 days', 'description': 'Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient withdrew consent from the Liposomal group just prior to 60 postoperative days, and three patients withdrew consent from the control group at the end of days 2, 3, and 4. The other missing data is from patients who lost to follow up from both groups.'}, {'type': 'SECONDARY', 'title': 'Incidence of Distress From Block Numbness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'OG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'classes': [{'title': 'PACU distress', 'categories': [{'title': 'No distress', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'any distress', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Missing data', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'POD2 Distress', 'categories': [{'title': 'No distress', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'any distress', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Missing data', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Any distress on PACU', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.947', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Postoperative day 2', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At PACU and Postoperative day 2', 'description': 'On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Although one patient from the control group decided to withdraw consent at the end of the second day following surgery, their data was included for this outcome as the withdrawal happened after collection. However, there was some missing data.'}, {'type': 'SECONDARY', 'title': 'Duration of Sensory Nerve Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'OG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'classes': [{'title': 'Full sensation', 'categories': [{'title': 'Returned on day 1 after the block', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Returned on day 2-60', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Not by day 60', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Missing data', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'First sensation', 'categories': [{'title': 'Returned on day 1 after the block', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Returned on day 2-60', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Not by day 60', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing data', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.441', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Full sensation', 'statisticalMethod': 'Fishers Freeman Halton', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.691', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'First sensation', 'statisticalMethod': 'Fishers Freeman Halton', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1, after Day 1 (day 2 to 60), and at postoperative day 60', 'description': 'Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Day of the Final Opioids Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'OG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '.876', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '0-96 postoperative hours', 'description': 'The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.', 'unitOfMeasure': 'day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients were missing from (Bupivacaine 0.5% with Adjuncts) group because of withdrawal.'}, {'type': 'SECONDARY', 'title': 'Motor Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'OG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'classes': [{'title': 'Any movement in PACU', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any movement in day1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any movement after day1', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Any movement missing data', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Return of full movement day 2-60', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Not yet by day 60', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Return of full movement missing data', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.011', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Any movement', 'statisticalMethod': "Fisher' Freeman Halton", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.536', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Full movement', 'statisticalMethod': 'Fishers Freeman Halton', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.', 'description': 'The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5):\n\n0= No detectable muscle contraction (visible or palpation)\n\n1. Detectable contraction (visible or palpation), but no movement achieved\n2. Limb movement achieved, but unable to move against gravity\n3. Limb movement against the resistance of gravity\n4. Limb movement against gravity and external resistance\n5. Normal strength\n\nThe results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Amount of Opioid Consumed During the Indicated Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'OG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'classes': [{'title': '0-24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000', 'lowerLimit': '25.00', 'upperLimit': '39.37'}, {'value': '25.00', 'groupId': 'OG001', 'lowerLimit': '25.00', 'upperLimit': '37.50'}]}]}, {'title': '24-48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '38.75'}, {'value': '23.25', 'groupId': 'OG001', 'lowerLimit': '9.75', 'upperLimit': '39.37'}]}]}, {'title': '48-72 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '8.00'}, {'value': '5.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '15.00'}]}]}, {'title': '72-120 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '27.00'}, {'value': '15.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '37.50'}]}]}], 'analyses': [{'pValue': '.648', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'MME 0-24', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.285', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'MME24-48', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.122', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'MME48-72', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.367', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'MME 72-120', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '0-24, 24-48, 48-72, and 72-120 postoperative hours.', 'description': 'Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours.', 'unitOfMeasure': 'MME/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient withdrew consent on the second postoperative day from the control group, then two patients withdrew on the third and fourth postoperative days from the control group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'FG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}], 'periods': [{'title': 'Preoperative-48 Hours Postoperative', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '48-96 Hours Postoperative', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'A patient who was lost to follow-up from the previous period came back for this period of the study', 'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': '60 Postoperative Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block'}, {'id': 'BG001', 'title': 'Bupivacaine 0.5% With Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000', 'lowerLimit': '66.5', 'upperLimit': '77.0'}, {'value': '73', 'groupId': 'BG001', 'lowerLimit': '66.5', 'upperLimit': '78.0'}, {'value': '73', 'groupId': 'BG002', 'lowerLimit': '66.75', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '31.30', 'groupId': 'BG000', 'lowerLimit': '27.25', 'upperLimit': '33.65'}, {'value': '31.60', 'groupId': 'BG001', 'lowerLimit': '27.00', 'upperLimit': '35.850'}, {'value': '31.35', 'groupId': 'BG002', 'lowerLimit': '27.25', 'upperLimit': '34.23'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'ASA Physical Status Classification', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'description': 'American Society of Anesthesiologists (ASA) physical status classification. ASA scale ranges (1-6), where 1 is the best while 6 is the worst ASA I = A normal healthy patient ASA II = A patient with mild systemic disease ASA III = A patient with severe systemic disease ASA IV = A patient with severe systemic disease that is a constant threat to life ASA V = A moribund patient who is not expected to survive without the operation ASA VI = A declared brain-dead patient whose organs are being removed for donor purposes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Preoperative shoulder pain', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'Diabetes Miletus : yes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes Miletus : no', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Hyperlipidemia : yes', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Hyperlipidemia : no', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension : yes', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension : no', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'COPD : yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'COPD : no', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'RA : yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'RA : no', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'Opioids at home : yes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Opioids at home : no', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-02', 'size': 283453, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-13T09:42', 'hasProtocol': True}, {'date': '2021-09-08', 'size': 200070, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-13T09:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'single-center, prospective, randomized controlled cross-sectional study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2019-03-21', 'resultsFirstSubmitDate': '2023-07-17', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-11', 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total Amount of Opioid Consumed During the Indicated Time Periods', 'timeFrame': '0-24, 24-48, 48-72, and 72-120 postoperative hours.', 'description': 'Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours.'}], 'primaryOutcomes': [{'measure': 'Total Opioid Consumption', 'timeFrame': 'Up to 120 postoperative hours', 'description': 'Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)'}], 'secondaryOutcomes': [{'measure': 'Time to First Opioid Medication', 'timeFrame': 'from the time of the block injection until discharge, assessed up to 72 postoperative hours.', 'description': 'From block time to the first dose of opioids given, measured in hours.'}, {'measure': 'Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours', 'timeFrame': '24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60', 'description': 'Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain.'}, {'measure': 'Hospital Length-of-stay', 'timeFrame': 'From the date of admission until discharge, assessed up to 72 hours.', 'description': 'From the date and time of admission to the date and time of discharge, Measured in hours.'}, {'measure': 'Assessment of Patient Overall Satisfaction With Pain Control', 'timeFrame': 'POD4 - 60 days', 'description': 'Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate.'}, {'measure': 'Incidence of Distress From Block Numbness', 'timeFrame': 'At PACU and Postoperative day 2', 'description': 'On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day.'}, {'measure': 'Duration of Sensory Nerve Block', 'timeFrame': 'Day 1, after Day 1 (day 2 to 60), and at postoperative day 60', 'description': 'Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60.'}, {'measure': 'Day of the Final Opioids Used', 'timeFrame': '0-96 postoperative hours', 'description': 'The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.'}, {'measure': 'Motor Recovery', 'timeFrame': 'PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.', 'description': 'The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5):\n\n0= No detectable muscle contraction (visible or palpation)\n\n1. Detectable contraction (visible or palpation), but no movement achieved\n2. Limb movement achieved, but unable to move against gravity\n3. Limb movement against the resistance of gravity\n4. Limb movement against gravity and external resistance\n5. Normal strength\n\nThe results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brachial Plexus', 'Liposomal Bupivacaine', 'Dexamethasone', 'Interscalene', 'Bupivacaine', 'Shoulder Arthroplasty', 'Regional anesthesia', 'Exparel'], 'conditions': ['Post-operative Pain', 'Total Shoulder Arthroplasty', 'Osteoarthritis of the Shoulder', 'Pain Management']}, 'referencesModule': {'references': [{'pmid': '28403427', 'type': 'BACKGROUND', 'citation': 'Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.'}, {'pmid': '20009936', 'type': 'BACKGROUND', 'citation': 'Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.'}, {'pmid': '16368840', 'type': 'BACKGROUND', 'citation': 'Movafegh A, Razazian M, Hajimaohamadi F, Meysamie A. Dexamethasone added to lidocaine prolongs axillary brachial plexus blockade. Anesth Analg. 2006 Jan;102(1):263-7. doi: 10.1213/01.ane.0000189055.06729.0a.'}, {'pmid': '20814282', 'type': 'BACKGROUND', 'citation': "Parrington SJ, O'Donnell D, Chan VW, Brown-Shreves D, Subramanyam R, Qu M, Brull R. Dexamethasone added to mepivacaine prolongs the duration of analgesia after supraclavicular brachial plexus blockade. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):422-6. doi: 10.1097/AAP.0b013e3181e85eb9."}, {'pmid': '23755801', 'type': 'BACKGROUND', 'citation': 'Rasmussen SB, Saied NN, Bowens C Jr, Mercaldo ND, Schildcrout JS, Malchow RJ. Duration of upper and lower extremity peripheral nerve blockade is prolonged with dexamethasone when added to ropivacaine: a retrospective database analysis. Pain Med. 2013 Aug;14(8):1239-47. doi: 10.1111/pme.12150. Epub 2013 Jun 11.'}, {'pmid': '29305103', 'type': 'BACKGROUND', 'citation': 'McLaughlin DC, Cheah JW, Aleshi P, Zhang AL, Ma CB, Feeley BT. Multimodal analgesia decreases opioid consumption after shoulder arthroplasty: a prospective cohort study. J Shoulder Elbow Surg. 2018 Apr;27(4):686-691. doi: 10.1016/j.jse.2017.11.015. Epub 2018 Jan 3.'}, {'pmid': '22956491', 'type': 'BACKGROUND', 'citation': 'Candiotti K. Liposomal bupivacaine: an innovative nonopioid local analgesic for the management of postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):19S-26S. doi: 10.1002/j.1875-9114.2012.01183.x.'}, {'pmid': '28479257', 'type': 'BACKGROUND', 'citation': 'Abildgaard JT, Lonergan KT, Tolan SJ, Kissenberth MJ, Hawkins RJ, Washburn R 3rd, Adams KJ, Long CD, Shealy EC, Motley JR, Tokish JM. Liposomal bupivacaine versus indwelling interscalene nerve block for postoperative pain control in shoulder arthroplasty: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2017 Jul;26(7):1175-1181. doi: 10.1016/j.jse.2017.03.012. Epub 2017 May 4.'}, {'pmid': '28005096', 'type': 'BACKGROUND', 'citation': 'Hannan CV, Albrecht MJ, Petersen SA, Srikumaran U. Liposomal Bupivacaine vs Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Retrospective Cohort Analysis. Am J Orthop (Belle Mead NJ). 2016 Nov/Dec;45(7):424-430.'}, {'pmid': '28843463', 'type': 'BACKGROUND', 'citation': 'Wang K, Zhang HX. Liposomal bupivacaine versus interscalene nerve block for pain control after total shoulder arthroplasty: A systematic review and meta-analysis. Int J Surg. 2017 Oct;46:61-70. doi: 10.1016/j.ijsu.2017.08.569. Epub 2017 Aug 24.'}, {'pmid': '26117072', 'type': 'BACKGROUND', 'citation': 'Schroer WC, Diesfeld PG, LeMarr AR, Morton DJ, Reedy ME. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial. J Arthroplasty. 2015 Sep;30(9 Suppl):64-7. doi: 10.1016/j.arth.2015.01.059. Epub 2015 Jun 3.'}, {'pmid': '28157791', 'type': 'BACKGROUND', 'citation': 'Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.'}]}, 'descriptionModule': {'briefSummary': 'This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty. Primary endpoint will be total opioid consumption in the first three post-operative days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age \\>18 years;\n* Lack of language barrier;\n* Informed consent obtained;\n* Presenting for primary total shoulder arthroplasty (TSA), both anatomic and reverse, by a specialty-trained surgeon;\n* American Society of Anesthesiology (ASA) physical status score I- III\n\nExclusion Criteria:\n\n* Presence of a language barrier;\n* Inability to complete telephone and/or paper questionnaire;\n* Lack of consent;\n* Allergy to local anesthetic;\n* Chronic pain syndrome and/or preoperative opioid use \\> 50 MME per day (including extended-release formulations and methadone);\n* Preoperative consultation to chronic pain service;\n* History of (\\<3 months) or current substance abuse, including any illicit drugs or excessive alcohol consumption as defined by the Office of Disease Prevention and Health Promotion (4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men);\n* Baseline peripheral neuropathy of the brachial plexus;\n* Contraindication to receiving single shot peripheral nerve blockade; including antithrombotic medications as per most recent American Society of Regional - - -Anesthesiology (ASRA) guidelines 17 , coagulopathy or coagulation disorder, or infection at injection site;\n* Severe chronic obstructive pulmonary disease (COPD) or other significant pulmonary disease where interscalene nerve block would be contraindicated due to concern for respiratory failure from phrenic nerve palsy;\n* Weight \\< 45 kg, given concern for local anesthetic toxicity at dosages given for the study; ASA score IV-V;\n* Revision arthroplasty;\n* Anatomic abnormality that limits or prevents the patient from receiving an interscalene nerve block;\n* Pregnant, nursing, or planning to become pregnant during the study or within 1 month after the shoulder replacement surgery'}, 'identificationModule': {'nctId': 'NCT03887650', 'briefTitle': 'LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs', 'organization': {'class': 'OTHER', 'fullName': 'Hartford Hospital'}, 'officialTitle': 'LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus', 'orgStudyIdInfo': {'id': 'HHC-2018-0231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liposomal Bupivacaine 1.3%', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block', 'interventionNames': ['Drug: Liposomal Bupivicaine 1.3%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine 0.5% with Adjuncts', 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block', 'interventionNames': ['Drug: Bupivacaine 0.5%']}], 'interventions': [{'name': 'Liposomal Bupivicaine 1.3%', 'type': 'DRUG', 'description': '10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block', 'armGroupLabels': ['Liposomal Bupivacaine 1.3%']}, {'name': 'Bupivacaine 0.5%', 'type': 'DRUG', 'otherNames': ['epinephrine', 'dexamethasone preservative-free'], 'description': '20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block', 'armGroupLabels': ['Bupivacaine 0.5% with Adjuncts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Bone and Joint Institute at Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Kevin Finkel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hartford Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hartford Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kevin Finkel', 'investigatorAffiliation': 'Hartford Hospital'}}}}