[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06484192":3,"trial-entities:NCT06484192":92,"trial-summary:NCT06484192":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":50,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":17,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":75,"locations":78,"central_contacts":88,"overall_officials":89,"references":90,"see_also_links":91},"NCT06484192","CKEP2024.0800","Pain Control After Lumbar Spine Fusion","Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion","UNKNOWN","2025-06-30","2024-06","2024-07-03","2024-06-28","Rothman Institute Orthopaedics","OTHER",false,"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.",null,[19,20,21],"Spine Fusion","NSAID (Non-Steroidal Anti-Inflammatory Drug)","Postoperative Pain",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE4",{"count":28,"type":29},428,"ESTIMATED",[31,37,41,46],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Naproxen 500 Mg","participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed",[36],"Group 1: NSAID Group",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Ketorolac","participants will receive Ketorolac (15 mg) immediately after surgery",[36],{"type":32,"name":42,"description":43,"armGroupLabels":44},"OxyCODONE 5 mg Oral Tablet","participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed",[36,45],"Group 2: Control Group",{"type":32,"name":47,"description":48,"armGroupLabels":49},"Metaxalone 800 MG","participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed",[36,45],[51],{"measure":52,"description":53,"timeFrame":54},"Fusion failure","Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays","2 years",[],"ALL","18 Years",true,{"inclusion":60,"exclusion":64,"raw_text":74},[61,62,63],"≥18 years of age, ≥1-level planned lumbar spinal fusion","Capacity to enroll","English speaking",[65,66,67,68,69,70,71,72,73],"Chronic kidney disease (preoperative creatinine ≥1.4)","History of gastrointestinal bleed or peptic ulcer disease","History of spinal fusion nonunion","Non-steroidal anti-inflammatory drug allergy","Previously diagnosed coagulopathy","Preoperative thrombocytopenia (platelets \\\u003C100,000)","Connective tissue disease","Operative indication due to infection, neoplasm, or trauma","Currently pregnant","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 \\\u003C100,000)\n* Connective tissue disease\n* Operative indication due to infection, neoplasm, or trauma\n* Currently pregnant",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"city":81,"state":82,"zip":83,"country":84,"geoPoint":85},"Rothman Orthopaedic Institute","Philadelphia","Pennsylvania","19107","United States",{"lat":86,"lon":87},39.95238,-75.16362,[],[],[],[],{"nct_id":4,"conditions":93,"biomarkers":96},[94,95],"Post-Operative Pain","Spine fusion",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]