Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 428
- 试验地点
- 1
- 主要终点
- Fusion failure
研究概览
简要总结
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.
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 (Investigator)
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
研究组 & 干预措施
Group 1: NSAID Group
Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
干预措施: Naproxen 500 Mg (Drug)
Group 1: NSAID Group
Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
干预措施: Ketorolac (Drug)
Group 1: NSAID Group
Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
干预措施: OxyCODONE 5 mg Oral Tablet (Drug)
Group 1: NSAID Group
Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
干预措施: Metaxalone 800 MG (Drug)
Group 2: Control Group
Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery
干预措施: OxyCODONE 5 mg Oral Tablet (Drug)
Group 2: Control Group
Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery
干预措施: Metaxalone 800 MG (Drug)
结局指标
主要结局
Fusion failure
时间窗: 2 years
Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays
次要结局
未报告次要终点