A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 150 mg Will Improve Pain Control in Patients With Hepatocellular Carcinoma Undergoing Partial Hepatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative Opioid Consumption
研究概览
简要总结
Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine consumption in the first 48 hours is documented. Postoperative pain is measured by the visual analogue scale (VAS) score.
详细描述
Methods: In this Randomized Controlled Trial, patients undergoing partial hepatectomy will be administered a single pre-operative dose of Pregabalin or a placebo. Primary endpoints are as follows:
- Post-operative analgesic requirements
- Post-operative VAS scale (rated 0-10)
- Complications
- Post-operative antiemetic requirement
- Length of stay
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
- 否
入选标准
- •patients undergoing partial hepatectomy
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
Pregabalin
Single, 150 mg pre-operative oral dose of Pregabalin
干预措施: Pregabalin (Drug)
Sugar Pill
Single, placebo pre-operative dose
干预措施: Placebo (for Pregabalin) (Drug)
结局指标
主要结局
Postoperative Opioid Consumption
时间窗: 48 hours
次要结局
- Postoperative Pain Scores on the Visual Analog Scale(24 hours)
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital