Prophylaxis Against Postoperative Pain After Orthopedic Surgery: Does it Help to Give Fentanyl Before Start of Remifentanil/Propofol Based Anesthesia?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Less use of postoperative opioids
研究概览
简要总结
The aim of this trial is to examine the possibility that fentanyl 1,5 µgr/kg given intravenously (i.v.) before the start of remifentanil infusion for anesthesia gives less development of tolerance/hyperalgesia postoperative than fentanyl given at the end of surgery (the traditional method).
详细描述
Postoperative pain can contribute to reduction in the patient's well-being and, if it is pronounced, delayed rehabilitation and an increase in the total cost for nursing and treatment.
Experimental studies has shown that infusion of remifentanil over some period of time, can result in acute opioid tolerance and hyperalgesia (1-2).
One clinical trial has shown that intraoperative infusion of remifentanil gives acute opioid tolerance with subsequent increased postoperative pain and increased opioid consume postoperative (3).
The development of opioid tolerance probably has several mechanisms. One topical mechanism is opioid induced influence of N-methyl-d-aspartate (NMDA)-receptor and its intracellular second-messenger-systems. This results in central sensitization to pain stimulus in the dorsal horn and the brain (4-5), with following development of hyperalgesia.
Several strategies can be successful to reduce or prevent opioid induced hyperalgesia, for example NMDA-receptor antagonists, alfa-2 agonists, opioid rotation or combination of opioids with different receptor selectivity (6-8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men > 18 years.
- •Informed consent.
- •Elective day-orthopedic surgery: damage to anterior cruciate ligament and/or posterior cruciate ligament with or without medial collateral ligament.
排除标准
- •Patients who use nonsteroidal anti-inflammatory drugs (NSAID's) or are allergic to NSAID's.
- •Patients using steroids, anti-emetics, drugs or opioids.
结局指标
主要结局
Less use of postoperative opioids
Less visual analog scale (VAS) and verbal rating scale (VRS) in the treatment group
次要结局
未报告次要终点