Effectivness of Tramadol or Topic Lidocaine on Postoperative Analgesia in Laparoscopic Colorectal Resection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 主要终点
- Total opioid consumption
研究概览
简要总结
Comparison of different postoperative analgesia after laparoscopic colorectal surgery
详细描述
Postoperative pain treatment should be multimodal and opioid sparing. Thoracic epidural analgesia could relieve pain after laparoscopic surgery. Although ERAS guidelines suggest to use less invasive pain relieve technique, opioids are widely used perioperatively, despite of their side effects. Non-opioids and 5% lidocaine patches, used topicaly, could effectively reduce opioid consumption and their side effects.
Namely, efficient perioperative pain treatment is important to prevent late neuropathic pain, also after laparoscopic lower abdominal surgery. Its incidence is usually low compared to open surgery.
The aim of present study was to evaluate, if opioid consumption in laparoscopic colorectal surgery could be reduced with lidocaine patch at the wound site or with infusion of metamizole and tramadol and if the results meets epidural analgesia. We also compared the incidence of postoperative neuropathic pain among groups.
Prospective, randomised trial with 4 parallel groups was conducted at the University medical centre (UMC) Ljubljana. ASA (American Society of Anaesthesiologists) Class 2-3 high risk surgical patients from the Clinical department of abdominal surgery were included in the study. Adult patients that underwent laparoscopic colorectal surgery were included.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Randomised by random number generator after meeting the inclusion criteria.
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
- •scheduled elective laparoscopic colorectal surgery
排除标准
- •critical preoperative state, pregnant women, laparotomy and palliative procedures.
研究组 & 干预措施
PCA
Postoperative intravenous infusion of piritramid patient controlled analgesia (PCA) (piritramide 0.5 mg/ml; infusion 1,5 mg/h, bolus 1,5 mg, lock out 30 minutes)
干预措施: Comparison of analgesic efficacy protocol (Drug)
PCEA
Postoperative patient controlled epidural analgesia (epidural cathterer inserted into Th7-8 intervertebral space, 200 ml of 0.125% levobupivacaine, 4 mg of morphine, 0.075 mg of clonidine; infusion 5 ml/h, bolus 5 ml, lock out 30 minutes).
干预措施: Comparison of analgesic efficacy protocol (Drug)
tramadol
Continous postoperative infusion of tramadol 300 mg and metamizole 2,5 g (in 500 ml 0.9% NaCl, rate of infusion 40 ml/h)
干预措施: Comparison of analgesic efficacy protocol (Drug)
lidocaine
Postoperative topical lidocaine and PCA (piritramide 0.5 mg/ml; infusion 0.5 mg/h, bolus 1.5 mg, lock out 20 minutes)
干预措施: Comparison of analgesic efficacy protocol (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: 0-48 hours after surgical procedure
Measurement of piritramide consumprion
Presence of neuropathic pain
时间窗: first 3 months after surgery
Detecting of neuropathic pain using DN4 and PainDetect Questionnaire. These are clinically validated tools for detecting the presence of neuropathic pain and evaluating the severity.
次要结局
未报告次要终点
研究者
Alenka Spindler-Vesel
asoc. prof.
University Medical Centre Ljubljana