NCT02444897已完成3 期
The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
This study was designed to assess the effectiveness of epidural patient-controlled analgesia compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic gastrectomy. The investigators hypothesized that epidural PCA would be more effective in pain control than IV PCA even for laparoscopic gastrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma in stomach
- •Males or Females, aged≥19 years and ≤80 years
- •Scheduled as laparoscopic gastrectomy
- •Patient has given their written informed consent to participate in the study
排除标准
- •History of hypersensitivity for analgesics
- •Recent history of narcotic analgesics
- •Disability of central nerve system
- •Uncontrolled co-morbidity
研究组 & 干预措施
Epidural PCA group
Experimental
Epidural patient-controlled analgesia group
干预措施: Epidural PCA Ropivacaine (Drug)
IV PCA group
Active Comparator
Intravenous patient-controlled analgesia
干预措施: IV PCA Fentanyl+nefopam+Ramosetron (Drug)
结局指标
主要结局
VAS score
时间窗: 24 hours after operation
pain degree was checked at every 24hours for 5days after operation
次要结局
- number of participants with complication(for 5days after operation)
- Bowel motility(for 5days after operation)
研究者
Seung Wan Ryu
Director of Gastrointesinal surgery, associate professor
Keimyung University Dongsan Medical Center
研究点 (1)
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