Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT04867369
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2021-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arthur.hertling@nyulangone.org', 'phone': '212-598-6085', 'title': 'Arthur Hertling, MD', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All events with start dates occurring any time after informed consent is obtained (baseline) until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, up to 34 days total.', 'description': 'The study coordinator and PI were alerted if participants were admitted to the hospital. If they were admitted during the two week period, the PI determined if it was considered an adverse event related to the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Pecs II Block', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Surgical Infiltration', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Opioid Utilization for the First 24 Hours After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pecs II Block', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.'}, {'id': 'OG001', 'title': 'Surgical Infiltration', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '27.5'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '30.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24-Hours Post-Operation', 'description': 'Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery.', 'unitOfMeasure': 'morphine milligram equivalents', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pecs II Block', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.'}, {'id': 'OG001', 'title': 'Surgical Infiltration', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Typically 1-3 Hours Post-Operation', 'description': 'In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient-reported Numerical Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pecs II Block', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.'}, {'id': 'OG001', 'title': 'Surgical Infiltration', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 Hours Post-Operation', 'description': 'In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient-reported Numerical Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pecs II Block', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.'}, {'id': 'OG001', 'title': 'Surgical Infiltration', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3 Post-Operation', 'description': 'In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Reactions to Surgical Subpectoral Incision - Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pecs II Block', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.'}, {'id': 'OG001', 'title': 'Surgical Infiltration', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'Number of patients with movement during incision.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pecs II Block', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.'}, {'id': 'OG001', 'title': 'Surgical Infiltration', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'Number of patients with tachycardia during incision.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pecs II Block', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.'}, {'id': 'OG001', 'title': 'Surgical Infiltration', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative', 'description': 'Number of patients with sensation in bicep during incision.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pecs II Block', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.'}, {'id': 'FG001', 'title': 'Surgical Infiltration', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'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': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pecs II Block', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.'}, {'id': 'BG001', 'title': 'Surgical Infiltration', 'description': '80 patients scheduled for open biceps tenodesis\n\nBupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine.\n\nBupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '11.78', 'groupId': 'BG000'}, {'value': '55', 'spread': '11.785', 'groupId': 'BG001'}, {'value': '55', 'spread': '11.783', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', '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': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '69', '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': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-04', 'size': 761867, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-14T13:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'dispFirstSubmitDate': '2024-10-31', 'completionDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2021-04-28', 'resultsFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2021-04-28', 'dispFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-10', 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Utilization for the First 24 Hours After Surgery', 'timeFrame': 'Up to 24-Hours Post-Operation', 'description': 'Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery.'}], 'secondaryOutcomes': [{'measure': 'Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU)', 'timeFrame': 'Typically 1-3 Hours Post-Operation', 'description': 'In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain.'}, {'measure': 'Patient-reported Numerical Rating Scale (NRS) Score', 'timeFrame': '24 Hours Post-Operation', 'description': 'In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain.'}, {'measure': 'Patient-reported Numerical Rating Scale (NRS) Score', 'timeFrame': 'Day 3 Post-Operation', 'description': 'In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain.'}, {'measure': 'Number of Patients With Reactions to Surgical Subpectoral Incision - Movement', 'timeFrame': 'Intraoperative', 'description': 'Number of patients with movement during incision.'}, {'measure': 'Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia', 'timeFrame': 'Intraoperative', 'description': 'Number of patients with tachycardia during incision.'}, {'measure': 'Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep', 'timeFrame': 'Intraoperative', 'description': 'Number of patients with sensation in bicep during incision.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tendonitis']}, 'descriptionModule': {'briefSummary': 'A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between 18 and 75 years of age\n2. Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis\n\nExclusion Criteria:\n\n1. Patients younger than 18 and older than 75;\n2. Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;\n3. Patients who are allergic to oxycodone;\n4. Patients with diagnosed or self-reported cognitive dysfunction;\n5. Patients with a history of neurologic disorder that can interfere with pain sensation;\n6. Patients with a history of drug or recorded alcohol abuse;\n7. Patients who are unable to understand or follow instructions;\n8. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;\n9. Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;\n10. Patients with a BMI over 45;\n11. Any patient that the investigators feel cannot comply with all study related procedures;\n12. NYU Langone Health students, residents, faculty or staff members.'}, 'identificationModule': {'nctId': 'NCT04867369', 'briefTitle': 'Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis', 'orgStudyIdInfo': {'id': '20-01978'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pecs II block', 'description': '80 patients scheduled for open biceps tenodesis', 'interventionNames': ['Drug: Bupivacaine 20mL 0.5%', 'Drug: Bupivacaine 20mL 0.25%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical infiltration', 'description': '80 patients scheduled for open biceps tenodesis', 'interventionNames': ['Drug: Bupivacaine 20mL 0.5%', 'Drug: Bupivacaine up to 15mL 0.25%']}], 'interventions': [{'name': 'Bupivacaine 20mL 0.5%', 'type': 'DRUG', 'description': 'Interscalene nerve block with 20 mL 0.5% bupivacaine.', 'armGroupLabels': ['Pecs II block', 'Surgical infiltration']}, {'name': 'Bupivacaine 20mL 0.25%', 'type': 'DRUG', 'description': 'Pecs II fascial plane block with 20 mL 0.25% bupivacaine.', 'armGroupLabels': ['Pecs II block']}, {'name': 'Bupivacaine up to 15mL 0.25%', 'type': 'DRUG', 'description': 'Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.', 'armGroupLabels': ['Surgical infiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Arthur Hertling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required.', 'ipdSharing': 'YES', 'description': 'The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Uchenna.Umeh@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Requests may be directed to Uchenna.Umeh@nyulangone.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}