Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 428
- 试验地点
- 1
- 主要终点
- Revision surgery for symptomatic lumbar spinal fusion nonunion
研究概览
简要总结
This study will compare two common approaches to pain control after lumbar spinal fusion surgery. Participants will be randomly assigned to receive either standard pain medication alone or standard pain medication plus a short course of nonsteroidal anti-inflammatory drugs (NSAIDs), including intravenous ketorolac while in the hospital and oral naproxen for one week after discharge.
The main goal is to determine whether taking NSAIDs after surgery affects how well the spine heals by increasing the chance of needing another surgery because the bones did not fuse properly within 2 years. The study will also evaluate pain medication use, recovery, hospital readmissions, complications, physical therapy progress, patient-reported pain and function, and overall healing. The results will help determine whether NSAIDs can be used safely as part of pain management after lumbar spinal fusion surgery while potentially reducing the need for opioid medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Surgeon will be blinded to which group each patient is in. Surgeons will make the determinations regarding clinical course, need for further workup, and assessment of fusion status on radiographs and advanced imaging. Patients will not be notified explicitly unless they ask, and they will not receive any form of placebo medication.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age, ≥1-level planned lumbar spinal fusion
- •Capacity to enroll
- •English speaking
排除标准
- •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 <100,000)
- •Connective tissue disease
- •Operative indication due to infection, neoplasm, or trauma
- •Currently pregnant
结局指标
主要结局
Revision surgery for symptomatic lumbar spinal fusion nonunion
时间窗: Up to 2 years after surgery
The proportion of participants who undergo revision lumbar fusion surgery for symptomatic nonunion (pseudarthrosis), as determined by the treating spine surgeon based on clinical evaluation and imaging findings.
次要结局
- Radiographic lumbar fusion status(6 months, 1 year, and 2 years after surgery)
- Inpatient opioid consumption(During the index hospitalization (up to approximately 3 days))
- Postoperative outpatient opioid consumption(2 weeks, 6 weeks, 6 months, 1 year, and 2 years after surgery)