Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Restoration of bowel function
研究概览
简要总结
Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.
详细描述
The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early postoperative physical activity recovery of patients scheduled for laparoscopic colorectal resection.
The study focuses on patients with colorectal disease, which receive the laparoscopic (assisted) surgical approach.
It is hypothesized that in those patients receiving perioperative and post-operative intravenous lidocaine, bowel function recovery will be faster, probably as a result of a significant opioid sparing, less pain and attenuated inflammatory response.
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
- Single (Outcomes Assessor)
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
- •scheduled to undergo laparoscopic colorectal 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
- •allergy to lidocaine
- •morbid obesity
- •patients with chronic opioid use.
研究组 & 干预措施
LIDOCAINE group
Beside general anesthesia, patients will receive intravenous lidocaine bolus 1.5 mg/kg just prior induction and an infusion of lidocaine 2mg/kg/h will be started and maintained during the whole surgical procedure. Entering the recovery room, this infusion will be decreased at the rate of 1mg/kg/hour for the 48 first hours
干预措施: Lidocaine (Drug)
Epidural group
Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.
干预措施: Thoracic epidural block (Procedure)
结局指标
主要结局
Restoration of bowel function
时间窗: 72 hours after an operation
次要结局
- Pain intensity(within 72 hours after an operation)
研究者
Gabriele Baldini, Assistant Professor
Dr
McGill University Health Centre/Research Institute of the McGill University Health Centre