Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Theoretical duration of hospitalization in intensive care unit.
研究概览
简要总结
Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and postoperative respiratory complications together with quicker recovery of bowel function. Currently, no studies have been able to prove its ability to reduce length of stay in intensive care and high-dependency units.
Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length of stay in intensive care unit after abdominal surgery under laparotomy.
详细描述
There are currently two methods of analgesia in postoperative abdominal surgery : patient-controlled analgesia (PCA) with opioids and epidural analgesia.
No international recommendations regarding the use of either of these techniques have yet been written. Epidural analgesia is superior to intravenous morphine, including during mobilization and coughing. It also reduces respiratory complications and optimizes postoperative rehabilitation. Nevertheless, mortality is not improved with this technique. Few publications exist on the optimization of the duration of hospitalization in the intensive care unit.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery scheduled under laparotomy
- •Extended ileal resection
- •Total proctocolectomy
- •Colectomy left/right/total
- •Rectosigmoidal resection
- •Anterior resection of rectum
- •Abdomino-perineal amputation
- •Adult patient
- •Written consent obtained
- •Planned hospitalization in the intensive care unit
- •Patient affiliated to social security
排除标准
- •Patients inapt to give consent
- •Emergency surgery
- •Contraindication to epidural analgesia
- •Contraindication to levobupivacaïne, morphine or sufentanil
- •Participation in another research protocol
- •Pregnancy or breastfeeding
结局指标
主要结局
Theoretical duration of hospitalization in intensive care unit.
时间窗: 5 days
The difference between the day of surgery and the day when discharge criteria for intensive care unit are met.
次要结局
- Total duration of hospitalization.(9 days)