Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1- and 3-years recurrence rate after surgery
研究概览
简要总结
Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on postoperative long and short term outcome in patients with pancreatic cancer undergoing surgery.
As short term endpoints: postoperative complications and resumption of bowel function.
Long term endpoints include: 1 and 3 year recurrence and mortality.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of pancreatic cancer
- •American Society of Anesthesiologists (ASA) risk I - III
排除标准
- •chronic pain
- •chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
- •contraindications for any of the study medications
- •significant psychiatric disorders (major depression, bipolar disorders, schizophrenia, etc.)
- •Convulsive disorders requiring medication during the last 2 years
- •liver cirrhosis/chronic kidney disease stage IV or V/chronic heart failure class III or IV/ decompensated diabetes
- •Corticoid dependent asthma
- •Autoimmune disorders
- •Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
- •Refusal for study participation
研究组 & 干预措施
Intravenous lidocaine
Patients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative
干预措施: Intravenous lidocaine (Drug)
Epidural ropivacaine
Patients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively
干预措施: Epidural ropivacaine (Drug)
结局指标
主要结局
1- and 3-years recurrence rate after surgery
时间窗: 3 years
Study participants will be contacted by study team via phone or e-mail
次要结局
- Complication rate after surgery(2 weeks)
- 1- and 3-years survival after surgery(3 years)
- Lidocaine and ropivacaine concentration(Intraoperatively)
研究者
Theodor Bot
PhD student
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor