NSAIDs and Time to Union in Diaphyseal Tibia Fractures: Do NSAIDs Make a Difference
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time to union
研究概览
简要总结
This study will attempt to determine if there is a statistic difference between the time to union, non-union rate and post-operative pain of patients who receive opioids for pain control vs. patients who receive NSAIDs and a reduced dosage of opioids for pain management
详细描述
The study will be a prospective interventional study with two randomized parallel groups.
Randomization will take place immediately following the identification of a potential participant. The control group will receive the standard of care for diaphyseal tibia fractures. The standard of care consists of intramedullary nailing and post-operative opioids for pain control. The interventional group will have the same surgical indication and intervention but will differ in the primary method of pain control. The study group will receive NSAIDs and a reduced dosage of opioids for pain control. Primary outcome measures will be time to union, non-union, and pain over the post-operative period measured by a VAS pain scale. Once the data collection of both groups is complete, the statistical analysis will begin to determine if there is a statistical difference between the control and study groups in the primary outcome measurements.
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
- None
入排标准
- 年龄范围
- 18 Years 至 105 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18 and 105
- •Diaphyseal tibia fracture (OTA/AO 42 A, B)
排除标准
- •Tibial fractures not treated with intramedullary nails
研究组 & 干预措施
NSAIDs
This arm is given NSAIDs perioperatively and after discharge
干预措施: NSAIDs (Drug)
结局指标
主要结局
Time to union
时间窗: through study completion, an average of 1 year
The time from surgery to bone healing
次要结局
未报告次要终点
研究者
Rodolfo Zamora, MD
Associate Professor
University of Louisville
