跳至主要内容
临床试验/NCT00240396
NCT00240396撤回不适用

Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家开始时间: 2005年10月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
pain score

研究概览

简要总结

The purpose of this prospective randomized study is to evaluate the risks and benefits of using bimodal analgesia, (i.e. Narcotics and NSAIDS) vs Narcotics alone post long bone fracture.

详细描述

This will be a prospective, randomized, control trial looking at the benefit of bimodal analgesia in the treatment of long bone fractures. The traditional pain control regimen following fracture fixation typically involves a course of narcotics on an as-needed basis for pain relief. Recent data has shown that adding NSAIDS to the pain regimen as part of a bimodal approach to pain control, improves the efficacy of pain management and reduces narcotic use. Laboratory research on NSAIDs as it pertains to bone healing, however, has shown in animal models that there may be a positive association between NSAIDS and non-union rates. In other words, NSAIDS may prevent or delay bone healing. These results, however, have not been tested prospectively in humans.

The purpose of this study is to look at the combination of NSAIDS and narcotics post long bone fracture and monitor the effects on narcotic use and healing rates to ultimately and conclusively establish the risk or benefit of NSAIDS after long bone fracture.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • skeletally mature patients over the age of 18 years
  • Fracture of Tibia, femur, or Humerus.

排除标准

  • Open fractures grade III
  • Open fractures with suspected compartment syndrome
  • history of prior fracture in particular limb.
  • Concurrent usage of Steroid drugs, and immunosuppressants.
  • Prior or current history of GI bleeding.

结局指标

主要结局

pain score

Amount of narcotics used

time to fracture healing

次要结局

  • complications
  • return to activity
  • reoperation rate

研究者

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

Lars Richardson

Instructor in Orthopedic Surgery, Part-time

Beth Israel Deaconess Medical Center

研究点 (2)

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