Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS) program.
Twenty patients will receive spinal analgesia and twenty patients will receive only Patient Control Analgesia (PCA).
详细描述
This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the ERAS program.
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
- •patients scheduled to undergo laparoscopic colonic resection
排除标准
- •patients who have trouble to understand, read or communicate either in French or in English
- •patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
- •patients suffering from severe cardiac or respiratory disease (status ASA IV)
- •patients suffering from metastatic carcinoma
- •patients who have a history of chemoradiation within the six months preceding surgery
- •morbid obesity
- •contraindication to spinal analgesia
研究组 & 干预措施
Spinal group
Isobaric bupivacaine 0.5% 10 mg together with preservative-free morphine was injected. The dose of morphine was based on patient's age, with 200 μg in patients aged ≤ 75 years and 150 μg in patients aged > 75 years.
干预措施: Spinal analgesia (Drug)
PCA group
PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.
干预措施: Patient Control Analgesia (PCA) Morphine (Drug)
结局指标
主要结局
postoperative pain
时间窗: daily during hospitalization up to 3 days after the operation
次要结局
- opioid consumption(daily during hospitalization up to 3 days after the operation)
- opioid side effects(daily during hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days)
研究者
Gabriele Baldini, Assistant Professor
Dr
McGill University Health Centre/Research Institute of the McGill University Health Centre