Epidural Oxycodone for Pain Management for Lower Limb Amputation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acute postoperative pain scores
研究概览
简要总结
The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation.
详细描述
Phantom limb pain (PLP) is often described as tingling, throbbing, sharp, pins/needles in the limb that is no longer there. It occurs more commonly in upper extremity amputations than lower extremities and tends to be intermittent in frequency. Pain severity varies, and onset can be immediate or years afterward.
The preventive strategies for the PLP pain are difficult to manage and if not addressed adequately may lead to chronic pain. The perioperative role of the anesthesiologist and the acute pain physician is important in the management of somatic and sometimes neuropathic postoperative pain.
Oxycodone is a semi-synthetic narcotic analgesic and historically has been a popular drug of abuse among the narcotic abusing population. Oxycodone is used orally or intravenously.
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)
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
- 否
入选标准
- •Age 18 to 65 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status II or III.
- •Undergoing lower limb amputation.
- •Under epidural anesthesia.
排除标准
- •Hypersensitivity to opioids.
- •Cardiac arrhythmias.
- •Acute asthma or other obstructive airways disease.
- •Severe renal impairment.
- •Pregnancy.
研究组 & 干预措施
Oxycodone (study group)
Patient will receive a bolus dose of 0.15 mg/kg plus 20 ml bupivacaine 0.25% followed by an infusion 0.03 mg/kg/h oxycodone plus 0.1 mL/Kg/h bupivacaine 0.125%.
干预措施: Oxycodone (Drug)
Bupivacaine (control group)
Patient will receive a bolus 20 ml bupivacaine 0.25% followed by an infusion 0.1 mL/Kg/h bupivacaine 0.125%.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Acute postoperative pain scores
时间窗: 48 hours postoperatively
Acute postoperative pain scores will be assessed using numerical rating scale (NRS).Each patient will be instructed about postoperative pain assessment with NRS. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at PACU, 2, 4, 6, 12, 24, 36 and 48 h postoperatively.
次要结局
- Time to the first request for the rescue analgesia(48 hours postoperatively)
- Postoperative morphine consumption(48 hours postoperatively)
- Incidence of phantom limb pain(3 months postoperatively)
- Adverse effects(48 hours postoperatively)
研究者
Gamal Hendawy Shams
Lecturer of Anesthesia and Postsurgical ICU, Faculty of Medicine, Kafrelshiekh University, Kafrelshiekh, Egypt
Kafrelsheikh University