Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT02695758
Status:
COMPLETED
Last Update Posted:
2016-03-01
First Post:
2016-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing TSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2016-02-22', 'studyFirstSubmitQcDate': '2016-02-24', 'lastUpdatePostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine and Morphine Equivalent consumption', 'timeFrame': '24 hours following surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis: Shoulder']}, 'descriptionModule': {'briefSummary': 'A non-blinded randomized controlled trial, in which participants undergoing primary reverse or total shoulder arthroplasty are randomly assigned to one of two treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. All individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at Methodist Hospital or Rothman Specialty Hospital.\n\nExclusion Criteria:\n\n1. Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia\n2. Revision arthroplasty, arthroplasty for fracture\n3. Unable/unwilling to consent for enrollment\n4. Unable to complete postoperative pain survey\n5. Known adverse drug reaction or allergy to the medications used\n6. Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain)\n7. Patients taking long acting narcotic pain medications (including extended release narcotic pain medications and methadone).\n8. Patients under the age of 18 years\n9. Patients with history of hepatic disease\n10. Pregnant women or women who are breastfeeding'}, 'identificationModule': {'nctId': 'NCT02695758', 'briefTitle': 'Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing TSA', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Local Intraoperative Analgesic Injection Versus Single Injection Interscalene Nerve Block in Patients Undergoing Shoulder Arthroplasty (TSA): A Randomized Trial', 'orgStudyIdInfo': {'id': '2016Nam2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'interscalene brachial plexus block', 'description': 'Direct interscalene nerve block injection via brachial plexus', 'interventionNames': ['Procedure: Interscalene brachial plexus block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine extended-release liposome injection', 'description': 'Infiltration of local anesthetic/analgesic, Bupivacaine extended-release liposome injection (Exparel) + Diluted in 40cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues.', 'interventionNames': ['Procedure: bupivacaine extended-release liposome injection']}], 'interventions': [{'name': 'Interscalene brachial plexus block', 'type': 'PROCEDURE', 'armGroupLabels': ['interscalene brachial plexus block']}, {'name': 'bupivacaine extended-release liposome injection', 'type': 'PROCEDURE', 'armGroupLabels': ['Bupivacaine extended-release liposome injection']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}