Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture
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
- 否
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
Lars Richardson
Instructor in Orthopedic Surgery, Part-time
Beth Israel Deaconess Medical Center
