Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-26 @ 1:40 PM
Study NCT ID:
NCT04364867
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2020-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exparel for Total Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ryan.Krupp@nortonhealthcare.org', 'phone': '502-394-6341', 'title': 'Ryan Krupp MD', 'organization': 'Orthopedic Institute, Norton Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '90 days', 'description': 'Dislodgment of pain pump catheter', 'eventGroups': [{'id': 'EG000', 'title': 'Exparel', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nExparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pain Pump', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nPain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Catheter Dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score in the 24 Hours After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nExparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine'}, {'id': 'OG001', 'title': 'Pain Pump', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nPain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '3.37', 'spread': '2.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after surgery', 'description': 'Worst pain score (0 \\[none\\] to 10 \\[worst possible\\]) in the 24 hours after surgery', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score in the 48 Hours After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nExparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine'}, {'id': 'OG001', 'title': 'Pain Pump', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nPain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.53', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '4.70', 'spread': '3.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Worst pain score (0 \\[none\\] to 10 \\[worst possible\\]) in the 48 hours after surgery', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Morphine Milligram Equivalents at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nExparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine'}, {'id': 'OG001', 'title': 'Pain Pump', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nPain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.58', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '3.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Cumulative Morphine Milligram Equivalents consumed at 24 hours', 'unitOfMeasure': 'Morphine Milligram Equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Morphine Milligram Equivalents at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nExparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine'}, {'id': 'OG001', 'title': 'Pain Pump', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nPain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.58', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '4.19', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Cumulative Morphine Milligram Equivalents consumed at 48 hours', 'unitOfMeasure': 'Morphine Milligram Equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Morphine Milligram Equivalents at 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nExparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine'}, {'id': 'OG001', 'title': 'Pain Pump', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nPain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.58', 'spread': '00.88', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72hours', 'description': 'Cumulative Morphine Milligram Equivalents consumed at 72 hours', 'unitOfMeasure': 'Morphine Milligram Equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Score in the 72 Hours After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exparel', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nExparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine'}, {'id': 'OG001', 'title': 'Pain Pump', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nPain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.94', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '2.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'Worst pain score (0 \\[none\\] to 10 \\[worst possible\\]) in the 72 hours after surgery', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exparel', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nExparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine'}, {'id': 'FG001', 'title': 'Pain Pump', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nPain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exparel', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nExparel: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine'}, {'id': 'BG001', 'title': 'Pain Pump', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nPain Pump: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.5', 'spread': '6.96', 'groupId': 'BG000'}, {'value': '67.15', 'spread': '7.17', 'groupId': 'BG001'}, {'value': '66.68', 'spread': '6.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-24', 'size': 291416, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-10T10:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2020-04-24', 'resultsFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-05', 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score in the 24 Hours After Surgery', 'timeFrame': '24 hours after surgery', 'description': 'Worst pain score (0 \\[none\\] to 10 \\[worst possible\\]) in the 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Pain Score in the 48 Hours After Surgery', 'timeFrame': '48 hours', 'description': 'Worst pain score (0 \\[none\\] to 10 \\[worst possible\\]) in the 48 hours after surgery'}, {'measure': 'Cumulative Morphine Milligram Equivalents at 24 Hours', 'timeFrame': '24 hours', 'description': 'Cumulative Morphine Milligram Equivalents consumed at 24 hours'}, {'measure': 'Cumulative Morphine Milligram Equivalents at 48 Hours', 'timeFrame': '48 hours', 'description': 'Cumulative Morphine Milligram Equivalents consumed at 48 hours'}, {'measure': 'Cumulative Morphine Milligram Equivalents at 72 Hours', 'timeFrame': '72hours', 'description': 'Cumulative Morphine Milligram Equivalents consumed at 72 hours'}, {'measure': 'Pain Score in the 72 Hours After Surgery', 'timeFrame': '72 hours', 'description': 'Worst pain score (0 \\[none\\] to 10 \\[worst possible\\]) in the 72 hours after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Shoulder Arthroplasty', 'Post-operative Pain', 'Pain pump', 'Liposomal Bupivacaine'], 'conditions': ['Total Shoulder Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 72 hours after Total Shoulder Arthroplasty (TSA) compared to a pain pump. Secondary objectives are (1) to determine if patients on Exparel use less narcotics and (2) have earlier return of functional use of the involved arm after surgery compared to the pain pump and (3) if use of Exparel leads to cost savings\n\nMETHODS\n\nSample size:\n\nBased on prior studies on anesthetics for TSA, the mean worst pain score in the 24 hours after surgery was 5.4, based on a 0 to 10 scale. To detect a change of 2 points, alpha of 0.05, beta of 0.80, a sample size of 51 subjects in each group will be required. To account for drop-outs, a total of 60 subjects in each arm will be enrolled.\n\nInclusion criteria Patients undergoing unilateral primary TSA or reverse TSA Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears Surgery performed by the Principal Investigator Anesthesia administered by Co-Principal Investigator Willing and able to sign an Informed Consent Exclusion criteria Indication for surgery is fracture Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or depression Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) Has hepatic disease On workers compensation/disability/litigation Known adverse reaction to medications to be administered On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone) Home Oxygen requirement whether as needed or scheduled. Contralateral Phrenic Nerve paralysis / incompetence. Body Mass Index ≥ 50 Randomization will be a varied blocked randomization with blocks of 12, 15 and 18 using sealed envelopes\n\nTreatment arms:\n\nControl: Pain catheter based pain control. Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nInterventional: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nBoth arms will receive the same multimodal analgesia medications preoperatively. Celebrex 400mg PO, Gabapentin 600mg PO, Tylenol 1 gram PO, unless contraindicated.', 'detailedDescription': 'The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 73 hours after TSA compared to a pain pump. Secondary objectives are (1) to determine if patients on Exparel use less narcotics and (2) have earlier return of functional use of the involved arm after surgery compared to the pain pump and (3) if use of Exparel leads to cost savings\n\nMETHODS\n\nSample size:\n\nBased on prior studies on anesthetics for TSA, the mean worst pain score in the 24 hours after surgery was 5.4, based on a 0 to 10 scale. To detect a change of 2 points, alpha of 0.05, beta of 0.80, a sample size of 51 subjects in each group will be required. To account for drop-outs, a total of 60 subjects in each arm will be enrolled.\n\nInclusion criteria Patients undergoing unilateral primary TSA or reverse TSA Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears Surgery performed by the Principal Investigator Anesthesia administered by Co-Principal Investigator Willing and able to sign an Informed Consent Exclusion criteria Indication for surgery is fracture Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or depression Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) Has hepatic disease On workers compensation/disability/litigation Known adverse reaction to medications to be administered On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone) Home Oxygen requirement whether as needed or scheduled. Contralateral Phrenic Nerve paralysis / incompetence. Body Mass Index ≥ 50 Randomization will be a varied blocked randomization with blocks of 12, 15 and 18 using sealed envelopes\n\nTreatment arms:\n\nControl: Pain catheter based pain control. Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit infusing at 4cc/hr. The patient will go home with that device until it runs out.\n\nInterventional: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine\n\nBoth arms will receive the same multimodal analgesia medications preoperatively. Celebrex 400mg PO, Gabapentin 600mg PO, Tylenol 1 gram PO, unless contraindicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing unilateral primary TSA or reverse TSA\n* Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears\n* Surgery performed by the Principal Investigator\n* Anesthesia administered by Co-Principal Investigator\n* Willing and able to sign an Informed Consent\n\nExclusion criteria\n\n* Indication for surgery is fracture\n* Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or depression\n* Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia)\n* Has hepatic disease\n* On workers compensation/disability/litigation\n* Known adverse reaction to medications to be administered\n* On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone)\n* Home Oxygen requirement whether as needed or scheduled.\n* Contralateral Phrenic Nerve paralysis / incompetence.\n* Body Mass Index ≥ 50'}, 'identificationModule': {'nctId': 'NCT04364867', 'briefTitle': 'Exparel for Total Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Norton Healthcare'}, 'officialTitle': 'Randomized Clinical Trial of Exparel vs Pain Pump for Post-operative Pain Control After Total Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': '20-N0122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exparel', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine', 'interventionNames': ['Drug: Exparel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain pump', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit infusing at 4cc/hr. The patient will go home with that device until it runs out.', 'interventionNames': ['Drug: Pain Pump']}], 'interventions': [{'name': 'Exparel', 'type': 'DRUG', 'description': 'Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine', 'armGroupLabels': ['Exparel']}, {'name': 'Pain Pump', 'type': 'DRUG', 'description': 'Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit infusing at 4cc/hr. The patient will go home with that device until it runs out.', 'armGroupLabels': ['Pain pump']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Ryan Krupp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norton Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norton Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}