Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Blood lidocaine concentration (micrograms/ml)
研究概览
简要总结
Thoracic epidural analgesia (TEA) is the gold standard analgesia of the laparotomy in major abdominal surgery and can be associated with intravenous lidocaine or subtituted by intravenous lidocaine when TEA is contraindicated and in order to reduce the use of the morphinics in the perioperative period.
Side effects can be paralytic ileus or nausea and vomiting and delay the enhanced recovery after surgery.
Intravenous lidocaine and TEA share several properties like anti hyperalgesia, anti inflammatory effect, intestinal process, anti tumoral effect… which suggests an additive effect of their combination that was not studied yet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abdominal surgery by laparotomy
排除标准
- •laparoscopic abdominal surgery,
- •TEA contraindication,
- •ropivacaine contraindication
- •intravenous lidocaine contraindication
研究组 & 干预措施
thoracic epidural analgesia
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period
干预措施: Blood sample (Other)
thoracic epidural analgesia
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period
干预措施: Lidocain (Drug)
thoracic epidural analgesia
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period
干预措施: ropivacaine (Drug)
结局指标
主要结局
Blood lidocaine concentration (micrograms/ml)
时间窗: 30 minutes before the end of surgery
Lidocaine blood sample will be performed 30 min before the end of the surgery
blood lidocaine concentration (micrograms/ml)
时间窗: at the end of the surgery (assessed up to 2 hours)
lidocaine blood sample will be performed at the end of the infusion,
blood lidocaine and ropivacaine concentration (micrograms/ml)
时间窗: at 2 hours
lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA,
blood ropivacaine concentration (micrograms/ml)
时间窗: at 24 hours
ropivacaine blood sample 24h after the infusion of the TEA
次要结局
未报告次要终点