Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-02 @ 12:22 AM
Study NCT ID:
NCT06484192
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Control After Lumbar Spine Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}, {'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'C011301', 'term': 'metaxalone'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 428}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-06-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fusion failure', 'timeFrame': '2 years', 'description': 'Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spine Fusion', 'NSAID (Non-Steroidal Anti-Inflammatory Drug)', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age, ≥1-level planned lumbar spinal fusion\n* Capacity to enroll\n* English speaking\n\nExclusion Criteria:\n\n* Chronic kidney disease (preoperative creatinine ≥1.4)\n* History of gastrointestinal bleed or peptic ulcer disease\n* History of spinal fusion nonunion\n* Non-steroidal anti-inflammatory drug allergy\n* Previously diagnosed coagulopathy\n* Preoperative thrombocytopenia (platelets \\<100,000)\n* Connective tissue disease\n* Operative indication due to infection, neoplasm, or trauma\n* Currently pregnant'}, 'identificationModule': {'nctId': 'NCT06484192', 'briefTitle': 'Pain Control After Lumbar Spine Fusion', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion', 'orgStudyIdInfo': {'id': 'CKEP2024.0800'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: NSAID Group', 'description': 'Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery', 'interventionNames': ['Drug: Naproxen 500 Mg', 'Drug: Ketorolac', 'Drug: OxyCODONE 5 mg Oral Tablet', 'Drug: Metaxalone 800 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Control Group', 'description': 'Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery', 'interventionNames': ['Drug: OxyCODONE 5 mg Oral Tablet', 'Drug: Metaxalone 800 MG']}], 'interventions': [{'name': 'Naproxen 500 Mg', 'type': 'DRUG', 'description': 'participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed', 'armGroupLabels': ['Group 1: NSAID Group']}, {'name': 'Ketorolac', 'type': 'DRUG', 'description': 'participants will receive Ketorolac (15 mg) immediately after surgery', 'armGroupLabels': ['Group 1: NSAID Group']}, {'name': 'OxyCODONE 5 mg Oral Tablet', 'type': 'DRUG', 'description': 'participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed', 'armGroupLabels': ['Group 1: NSAID Group', 'Group 2: Control Group']}, {'name': 'Metaxalone 800 MG', 'type': 'DRUG', 'description': 'participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed', 'armGroupLabels': ['Group 1: NSAID Group', 'Group 2: Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}