NCT06513208招募中4 期
Ketorolac Effects on Post-operative Pain and Lumbar Fusion: a Double Blind Randomized Controlled Trial
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Ketorolac results in decreased post-op opioid use when administered in the first 48 hours (measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups).
研究概览
简要总结
A double blind prospective randomized trial of IV ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-85 years old (inclusive)
- •Elective posterior lumbar instrumented fusion
- •One or two level fusion
- •Consent to participate in study and willing to adhere to study follow up
- •English proficiency
排除标准
- •< 18 or > 85 years old
- •History of renal failure, dialysis, or creatinine over 1.50 mg/dl
- •Active or recent smoker (active within past 6 months)
- •Revision surgery
- •Auto/worker compensation
- •Active cancer or history of chemotherapy in past 6 months
- •Active narcotic use within 3 months of surgery date
- •Infection at operative levels
- •Any allergies to NSAIDs or Opioids
研究组 & 干预措施
Ketorolac arm
Active Comparator
干预措施: Ketorolac Tromethamine (Drug)
Placebo Arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Ketorolac results in decreased post-op opioid use when administered in the first 48 hours (measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups).
时间窗: 12 months
次要结局
- Ketorolac use does not decrease spinal fusion rates in one or two level fusion (failure defined as by > than 2 degrees motion on standardized flexion/extension x-rays compared to pre-op imaging analyzed by SpineCAMP software at 6 and 12 months post-op).(12 months)
- Ketorolac use decreases average length of hospital stay (length of stay for both the control group and the experimental group will be counted, and a statistical average for each group will be calculated and compared).(12 months)
研究者
研究点 (1)
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