Comparison of Two Kinds of Postoperative Analgesia After Amputation:a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
Pain after amputation is a significant problem among amputees. Phantom limb pain may appear in up to 85% of patients and is usually resistant to a wide variety of treatments.It is believed that regional anesthesia, by preventing the establishment of central sensitization, may play a role in reducing the incidence of acute and chronic pain. Therefore the investigators will compare two methods of postoperative analgesic after after amputation by their efficiency and complication.
详细描述
Peripheral nerve transection results in an afferent nociceptive barrage that initiates spinal cord hyperexcitability with expansion of the receptive fields of dorsal horn neurons that respond to the nearest intact afferents. These neuroplastic changes are believed to be responsible for the development of postsurgical chronic pain syndromes, including phantom limb and stump pain.At present, there are no randomized studies with sample sizes that ensure power, or blinded for end-point assessment,to support the evidence on pharmacological and non-pharmacological treatments of Pain after amputation. Consequently, our study was designed to arrive at clear conclusions about treatment efficacy and to give stronger recommendations for clinical practice.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of American Association of anesthetists（ASA）Grade 1 or 2
- •Aged between 18 and 65 years
- •Undergoing elective total knee replacement
排除标准
- •Mental illness can not match
- •Nerve block, epidural anesthesia contraindicated
- •People who have Slow-type arrhythmias
- •History of chronic headaches and long-term use of analgesic drugs
- •People who were postoperative consciousness, language or hearing impaired
研究组 & 干预措施
Local analgesic
This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia.
干预措施: Local analgesic (Procedure)
Local analgesic
This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia.
干预措施: ropivacaine (Drug)
Intravenous analgesic
This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg.
干预措施: Intravenous analgesic (Procedure)
Intravenous analgesic
This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg.
干预措施: flurbiprofen (Drug)
结局指标
主要结局
pain
时间窗: 72 hours postoperation
Up to 72 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.
次要结局
- Phantom pain(three months postoperation)
- complication(72 hours postoperation)
研究者
bo xu
associate chief physician
Guangzhou General Hospital of Guangzhou Military Command