NCT01484535已完成不适用
Aspiration for Pain Relief Following Ankle Fracture: A Prospective Double-Blind Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Pain as rated by numerical rating scale (NRS) scores in the emergency department and in the first 72 hours from the time of initial evaluation.
研究概览
简要总结
This trial will study the effect of hematoma aspiration in patients with acute ankle fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 未提供
排除标准
- •Any concomitant injuries affecting Numerical Rating Scale
- •Soft tissue wounds at aspiration sites that compromise ability to aspirate
- •Patient not able to complete pain medication log
- •Patient not able to participate in follow up
结局指标
主要结局
Pain as rated by numerical rating scale (NRS) scores in the emergency department and in the first 72 hours from the time of initial evaluation.
时间窗: 6 months
Total amount of pain medication used in the first 72 hours from time of initial evaluation.
次要结局
- Percentage of volumetric increase of the injured ankle compared to the uninjured ankle.(6 months)
研究者
Stephen A. Sems
Principal Investigator
Mayo Clinic
研究点 (2)
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