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
- 1
- 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
研究组 & 干预措施
Thoracic continuous epidural analgesia
Thoracic continuous epidural analgesia at T7-8 or T8-9 combined with IV PCA fentanyl (bolus mode only 15 ug/bolus, 5 minutes lockout, 4 hours limit 200 ug).
Multimodal analgesia Intraoperative : thoracic epidural infusion with 0.0625% bupivacaine with morphine 0.02 ug/ml 5 ml/h, morphine 2 mg epidurally are given.
Postoperative: 0.0625% bupivacaine with morphine 0.02 ug/ml 5 ml/h is given combined with IV patient-controlled analgesia; bolus mode only, fentanyl 15 ug/bolus, lockout interval 5 minutes, 4 hours limit 200ug, multimodal analgesia: paracetamol 1000 mg iv every 6 hours until patient can take orally, change to 1000 mg orally every 6 hours total 3 days, Parecoxib 40 mg IV x 4 doses then COX2 inhibitor (etoricoxib 90 mg orally x2 days)
干预措施: Thoracic continuous epidural analgesia (Procedure)
No CEA
IV PCA fentanyl, IV patient-controlled analgesia; bolus mode only, fentanyl 15 ug/bolus, lockout interval 5 minutes, 4 hours limit 200ug multimodal analgesia: paracetamol 1000 mg IV every 6 hours until patient can take orally, change to 1000 mg orally q 6 hours total 3 days, Parecoxib 40 mg IV x 4 doses then COX2 inhibitor (Etoricoxib 90 mg orally x2 days)
干预措施: Thoracic continuous epidural analgesia (Procedure)
结局指标
主要结局
Amount of postoperative opioid consumption
时间窗: postoperative 72 hours
amount of fentanyl (microgram)
Amount of postoperative opioid consumption
时间窗: postoperative 48 hours
amount of fentanyl (microgram)
Amount of postoperative opioid consumption
时间窗: postoperative 24 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