跳至主要内容
临床试验/NCT05332314
NCT05332314招募中4 期

NSAIDs and Time to Union in Diaphyseal Tibia Fractures: Do NSAIDs Make a Difference

University of Louisville2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月12日最近更新:
适应症
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
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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodolfo Zamora, MD

Associate Professor

University of Louisville

研究点 (2)

Loading locations...

相似试验