Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-10 @ 6:09 PM
Study NCT ID:
NCT07280195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723006', 'term': 'bupivacaine-meloxicam drug combination'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Narcotic consumption', 'timeFrame': 'From surgery to two-weeks following surgery', 'description': 'Narcotic consumption measured in morphine equivalent units (MEU)'}], 'secondaryOutcomes': [{'measure': 'Pain management cost', 'timeFrame': 'Perioperative', 'description': 'Total cost of the interscalene single shot block plus Zynrelef compared to the cost of the block plus catheter with pain pump'}, {'measure': 'Pain management administration', 'timeFrame': 'Perioperative', 'description': 'Time needed by the anesthesiologists to perform the blocks in both groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ZYNRELEF', 'Total shoulder arthroplasty'], 'conditions': ['Total Shoulder Arthroplasty', 'Pain Management']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if local intra-operative application of ZYNRELEF (topical medication) during shoulder replacement surgery improves pain control (as defined by opioid consumption after surgery) compared to the use of an interscalene block with catheter. This is a randomized clinical trial without blinding. Subjects will complete patient reported outcomes before and after surgery. Subjects will track their narcotic use, pain scores and pain satisfaction after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult patients 18 years or older\n2. Indicated to undergo primary total shoulder arthroplasty (anatomic or reverse)\n\nExclusion Criteria:\n\n1. Any persons unable to consent, will not be eligible\n2. Patients undergoing revision arthroplasty or reverse shoulder arthroplasty\n3. Proximal humerus fractures\n4. Inability to have interscalene anesthetic catheter placement\n5. Compromised baseline renal function (CrCl \\< 50)\n6. BMI \\> 40\n7. History of GI bleed, prior duodenal surgery, or gastric sleeve resection\n8. Current narcotic use or prior consistent narcotic exposure in the last 6 months\n9. Use of perioperative oral steroid medications\n10. Active Workman's compensation claim\n11. Prior shoulder arthroplasty on the contralateral side in which an interscalene catheter was used"}, 'identificationModule': {'nctId': 'NCT07280195', 'briefTitle': 'ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': '202509174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ZYNRELEF', 'interventionNames': ['Drug: Zynrelef']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interscalene block with continuous catheter pump', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Zynrelef', 'type': 'DRUG', 'description': 'ZYNRELEF', 'armGroupLabels': ['ZYNRELEF']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Interscalene block with continuous catheter pump', 'armGroupLabels': ['Interscalene block with continuous catheter pump']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'contacts': [{'name': 'Julianne Sefko', 'role': 'CONTACT', 'email': 'jsefko@wustl.edu', 'phone': '314-747-2496'}, {'name': 'Jay Keener, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Melissa Wright, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Benjamin Zmistowski, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Julianne Sefko', 'role': 'CONTACT', 'email': 'jsefko@wustl.edu', 'phone': '314-747-2496'}], 'overallOfficials': [{'name': 'Alexander Aleem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Alexander Aleem', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}