Post Operative Functional Restoration in Patients Undergoing Major Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative functional recovery
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 perioperative intravenous lidocaine has an impact on the early post operative physical activity recovery of patients scheduled for laparoscopic colon surgery.
Twenty patients will receive thoracic epidural analgesia, twenty patients will receive intravenous lidocaine plus patient-controlled analgesia (PCA) and twenty patients will receive only PCA.
Hypothesis: patients receiving perioperative intravenous lidocaine, post operative recovery 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
This is a blinded randomised study of patients undergoing major laparoscopic abdominal and pelvic surgery. The first group of patients will receive thoracic epidural analgesia, the second group will receive perioperative intravenous lidocaine, the third group will PCA alone and the last group will receive spinal analgesia. Functional restoration assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.
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 85 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
- •allergy to lidocaine
- •morbid obesity
研究组 & 干预措施
LIDOCAINE group
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
Epidural Group: Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.
干预措施: Epidural Block (Procedure)
PCA group
Beside general anesthesia, the patients will receive neither lidocaine nor epidural catheter. The patients will receive the same analgesia protocol consisting of PCA morphine for a total duration of 48 hours.
干预措施: PCA Morphine (Drug)
结局指标
主要结局
Postoperative functional recovery
时间窗: daily during hospitalization, and at 4 and 8 weeks after the surgery
次要结局
- postoperative pain(daily during hospitalization)
- opioid consumption(daily during hospitalization)
- opioid side effects(daily during hospitalization)
研究者
Gabriele Baldini, Assistant Professor
Dr
McGill University Health Centre/Research Institute of the McGill University Health Centre