Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery: Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Amount of postoperative opioid consumption
研究概览
简要总结
This prospective randomized controlled study is aimed to determine the advantages of thoracic epidural analgesia for open upper abdominal surgery in combination with multimodal analgesia compared with no thoracic epidural analgesia on postoperative pain control. The primary outcome is total opioid consumption in postoperative 72 hours. Secondary outcomes are the success of continuous epidural analgesia or complications of this technique, pain intensity, morbidity and mortality compare to no continuous epidural analgesia.
详细描述
Continuous epidural analgesia (CEA) for open upper abdominal surgery has been showed the analgesic analgesia for open abdominal surgery. However the technical difficulty, complications especially hypotension, pruritus of CEA impede the popularity of technique compared to intravenous patient-controlled analgesia (IV PCA) in multimodal analgesia. This study is aimed to study of the role of CEA and multimodal analgesia in open abdominal surgery compare to IV PCA.
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
盲法说明
Randomized group of patient is identified and sealed in envelope. Postoperative outcomes are assessed by Acute Pain Service nurse or resident.
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
- •age 18-80 years
- •open upper abdominal surgery
- •American Society of Anesthesiologists (ASA) grade I-III
排除标准
- •contraindications to CEA
- •inability communication
- •patient's refusal
- •emergency surgery
- •BMI > 35
结局指标
主要结局
Amount of postoperative opioid consumption
时间窗: postoperative 72 hours
amount of fentanyl (microgram)
次要结局
- Mortality(Up to 30 days postoperative)
- Intraoperative opioid usage(intraoperative)
- Length of hospital stay(days from patient admission until discharge, an average within 1 week)
- Percentage of patient to do out of bed activities(postoperative day 1)
- Pain intensity(postoperative 6 hours until 72 hours postoperative)
- Complications of thoracic epidural analgesia(postoperative 24 hours, 48 hours, 72 hours)
- Morbidity(Up to 30 days postoperative)
研究者
Suwimon Tangwiwat
associate professor, Department of Anesthesiology
Mahidol University