Improvement of Care of Patients Undergoing Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The norepinephrine consumption
研究概览
简要总结
The study is a randomised controlled trial comparing the effectivity and impact of epidural analgesia and wound catheter analgesia in patients undergoing pancreaticoduodenectomy. The aim of the study is to examine whether there are a difference in perioperative fluid therapy and complication rates between the patients in epidural and wound catheter groups.
详细描述
All patients undergoing pancreaticoduodenectomy in Helsinki University Hospital are recruited in the study. Patients meeting the inclusion criteria and giving consent to participate the study will be randomised to whether epidural analgesia group or wound catheter analgesia group. Both groups receive additional analgesia with intravenous PCA-oxycodone (patient controlled analgesia).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or over
- •patients who undergo pancreaticoduodenectomy
排除标准
- •patients to whom are made a major vascular reconstruction
- •patients with significant comorbidities and inability to use PCA
- •regural use of strong opioids or drugs preoperatively
- •patients with severe chronic pain issues
- •chronic atrial fibrillation
- •patients who refuse to take part to the study
研究组 & 干预措施
Epidural analgesia
干预措施: Analgesia via epidural catheter (Procedure)
Wound catheter analgesia
干预措施: Analgesia via wound catheter (Procedure)
结局指标
主要结局
The norepinephrine consumption
时间窗: Postoperative day 0
Norepinephrine consumption on POD 0
次要结局
- Fluid volumes on PODs 0-4(Postoperative days 0-4)
- Oxycodone consumption(Postoperative days 1-4)
- Hospital length of stay(Postoperative days 0-60)
- Postoperative complications(Postoperative days 0-90)
- Reoperation rates(Postoperative days 0-90)
- Readmission rates(Postoperative days 0-90)
- Mortality(postoperative day 0-90)
研究者
Piia Peltoniemi
M.D., Principal Investigator
Helsinki University Central Hospital