Preoperative Valdecoxib: CNS Penetration and Effects on Biochemical Markers of Pain and Sensitization
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cerebrospinal fluid (CSF) valdecoxib concentration
研究概览
简要总结
Surgery initiates a complex cascade of events involving the release of chemical compounds from nerve endings and damaged tissue which leads to an inflammatory and pain response. The purpose of this investigation is to measure various chemical mediators in the blood and cerebrospinal fluid, and to test the hypothesis that they will be decreased in patients treated with a COX-2 inhibitor.
详细描述
Surgery initiates a complex cascade of events involving the release of nociceptive compounds from nerve endings and damaged tissue which leads to an inflammatory and hyperalgesic response. COX-2 inhibitors are often used for treating pain. This is a double-blind randomized study in surgical patients receiving a spinal drain for surgical purposes. The hypothesis is that valdecoxib will reach therapeutic concentrations in CSF, and will decrease plasma and CSF concentrations of inflammatory mediators. Subjects will receive valdecoxib 40 mg or placebo approximately 1 hr prior to surgery. Serial blood and CSF samples will be obtained. Valdecoxib and cytokine concentrations will be measured.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgery requiring lumbar drain placement
排除标准
- •Contraindication to COX-2 inhibitor (renal or hepatic insufficiency)
- •Known adverse reaction to nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Use of NSAID or COX-2 within 7 days prior to surgery
结局指标
主要结局
Cerebrospinal fluid (CSF) valdecoxib concentration
次要结局
- Plasma valdecoxib concentration
- CSF/plasma valdecoxib concentration ratio
- CSF and plasma cytokine concentrations
- Postoperative opioid consumption
- Pain visual analogue scale (VAS) scores