NCT00957177已完成3 期
Effect of Preoperative Pregabalin Administration on the Postoperative Opioid Consumption in Patients Undergoing Nephrectomy
Medical University of Graz1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- postoperative opioid consumption
研究概览
简要总结
Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device for self delivering opioids. Morphine consumption in the first 48 hours is documented.
Hyperalgesia is measured by von-Frey-Filaments.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing elective nephrectomy
排除标准
- •contraindication against pregabalin
- •creatinine > 2.0 mg/dl
- •GGT >165, AST >105, ALT >135
- •peptic Ulcus
- •haemorrhagic diathesis
- •angina pectoris, myocardial infarction
- •bronchial asthma
- •opioid abuse
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Pregabalin group
Active Comparator
Receiving 300mg pregabalin preoperative
干预措施: Pregabalin (Drug)
结局指标
主要结局
postoperative opioid consumption
时间窗: 48 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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