Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-30 @ 9:30 AM
Study NCT ID:
NCT03845894
Status:
TERMINATED
Last Update Posted:
2023-11-13
First Post:
2019-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'jjaffe@wakehealth.edu', 'phone': '336-716-4498', 'title': 'Jonathan Doug Jaffe DO', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'description': 'events that occurred during first 24 hours after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Liposomal Bupivacaine ISB', 'description': 'Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bupivacaine With Adjuvants ISB', 'description': 'Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Pain Scores for the First 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine ISB', 'description': 'Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)'}, {'id': 'OG001', 'title': 'Bupivacaine With Adjuvants ISB', 'description': 'Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'There have been no studies to evaluate pain scores ISB w/ plain bupi+adjuvants. Power to detect difference at least 0.4 on the VAS scale. Threshold for inferiority is difference \\>=2 points on the VAS scale. Will use two-sample t test with α= 0.05 and β= 0.1. Postop opioid consumption, total post-op opioid @ 1st 48 hours in oxycodone equivalents. Mean opioid consumption per cohort is calculated, \\& the cohorts compared for statistical difference with two-sample t test, with α= 0.05 and β= 0.1.'}], 'paramType': 'MEAN', 'timeFrame': 'At 48 hours postoperatively', 'description': 'Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The software interface in this website will not allow for AUC as an acceptable outcome to satisfy field entries. Therefore, here the AUC is not reported here, but rather then mean and standard deviation are reported.'}, {'type': 'SECONDARY', 'title': 'Postoperative Opioid Consumption for the First 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine ISB', 'description': 'Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)'}, {'id': 'OG001', 'title': 'Bupivacaine With Adjuvants ISB', 'description': 'Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 48 hours', 'description': 'Morphine milligram equivalents (MME) over a 48 hour period', 'unitOfMeasure': 'Morphine milligram equivalents (MME)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Surgical Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine ISB', 'description': 'Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)'}, {'id': 'OG001', 'title': 'Bupivacaine With Adjuvants ISB', 'description': 'Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.75', 'spread': '.45', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '1.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 48 hours', 'description': 'Satisfaction scale is from 1-5, with the higher score being highest level of satisfaction', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liposomal Bupivacaine ISB', 'description': 'Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)'}, {'id': 'FG001', 'title': 'Bupivacaine With Adjuvants ISB', 'description': 'Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liposomal Bupivacaine ISB', 'description': 'Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)'}, {'id': 'BG001', 'title': 'Bupivacaine With Adjuvants ISB', 'description': 'Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', '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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', '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': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-09', 'size': 528742, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-25T08:45', 'hasProtocol': True}, {'date': '2022-04-05', 'size': 191231, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-11-01T14:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'feasibility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2019-01-22', 'resultsFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-10', 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Pain Scores for the First 48 Hours', 'timeFrame': 'At 48 hours postoperatively', 'description': 'Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Opioid Consumption for the First 48 Hours', 'timeFrame': 'up to 48 hours', 'description': 'Morphine milligram equivalents (MME) over a 48 hour period'}, {'measure': 'Satisfaction With Surgical Experience', 'timeFrame': 'at 48 hours', 'description': 'Satisfaction scale is from 1-5, with the higher score being highest level of satisfaction'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shoulder Replacement Surgery', 'Interscalene Nerve Block', 'Liposomal Bupivacaine', 'Shoulder pain', 'Regional anesthesia', 'Brachial plexus blockade'], 'conditions': ['Shoulder Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '27732710', 'type': 'BACKGROUND', 'citation': 'Sakamoto B, Keiser S, Meldrum R, Harker G, Freese A. Efficacy of Liposomal Bupivacaine Infiltration on the Management of Total Knee Arthroplasty. JAMA Surg. 2017 Jan 1;152(1):90-95. doi: 10.1001/jamasurg.2016.3474.'}, {'pmid': '28146271', 'type': 'BACKGROUND', 'citation': 'Hamilton TW, Athanassoglou V, Mellon S, Strickland LH, Trivella M, Murray D, Pandit HG. Liposomal bupivacaine infiltration at the surgical site for the management of postoperative pain. Cochrane Database Syst Rev. 2017 Feb 1;2(2):CD011419. doi: 10.1002/14651858.CD011419.pub2.'}, {'pmid': '29787389', 'type': 'BACKGROUND', 'citation': 'Pichler L, Poeran J, Zubizarreta N, Cozowicz C, Sun EC, Mazumdar M, Memtsoudis SG. Liposomal Bupivacaine Does Not Reduce Inpatient Opioid Prescription or Related Complications after Knee Arthroplasty: A Database Analysis. Anesthesiology. 2018 Oct;129(4):689-699. doi: 10.1097/ALN.0000000000002267.'}, {'pmid': '27558150', 'type': 'BACKGROUND', 'citation': 'Hamilton TW, Athanassoglou V, Trivella M, Strickland LH, Mellon S, Murray D, Pandit HG. Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. Cochrane Database Syst Rev. 2016 Aug 25;2016(8):CD011476. doi: 10.1002/14651858.CD011476.pub2.'}, {'type': 'BACKGROUND', 'citation': 'Rabin T. FDA In Brief: FDA approves new use of Exparel for nerve block pain relief following shoulder surgeries.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.', 'detailedDescription': 'The primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (ISB) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. Principal Investigators hypothesize that ISB using plain bupivacaine with adjuvants will provide similar pain relief as ISB using liposomal bupivacaine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing total shoulder arthroplasty (not a reverse)\n* Age ≥ 18 years\n* Ability to understand and the willingness to sign an IRB-approved informed consent document.\n* ASA patient status I-III patients\n* Weight Greater than or equal to 50 kg\n\nExclusion Criteria:\n\n* Contraindications to an interscalene block or phrenic blockade\n* Infection at injection site\n* Pre-existing neurological dysfunction affecting the operative extremity\n* Chronic pain diagnosis or opioid use \\>40mg oxycodone daily equivalents or use of long-acting opioids\n* BMI \\>40\n* Uncontrolled diabetes (A1c \\>8.0)\n* Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or opioid) in the postsurgical period for pain not strictly related to the surgery\n* Contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.)\n* Patients who are wards of the state\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.\n* Patients with moderate-severe hepatic or renal impairment'}, 'identificationModule': {'nctId': 'NCT03845894', 'briefTitle': 'Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Single Injection Interscalene Brachial Plexus Nerve Block With Adjuvants vs. Liposomal Bupivacaine Interscalene Brachial Plexus Nerve Block for Total Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'IRB00055981'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liposomal Bupivacaine Interscalene brachial plexus (ISB)', 'interventionNames': ['Drug: Liposomal bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine with adjuvants ISB', 'interventionNames': ['Drug: Bupivacaine with adjuvants']}], 'interventions': [{'name': 'Liposomal bupivacaine', 'type': 'DRUG', 'description': 'Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)', 'armGroupLabels': ['Liposomal Bupivacaine Interscalene brachial plexus (ISB)']}, {'name': 'Bupivacaine with adjuvants', 'type': 'DRUG', 'description': 'Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.', 'armGroupLabels': ['Bupivacaine with adjuvants ISB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Doug Jaffe, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Available after study conclusion, for up to 3 years afterward.', 'ipdSharing': 'YES', 'description': 'Will be shared upon request: raw data and statistical calculations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}