The Analgesic Efficacy and Safety of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty: A Randomized Triple-Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Improving A post-anesthesia care unit (PACU) pain score.
研究概览
简要总结
Oxycodone showed similar or superior analgesic effects than fentanyl and was proposed as an alternative for fentanyl for pain control in the postoperative period. However, it was mainly directed to control visceral pain, due to the mediation of analgesic effects by the kappa receptors. However, few studies compared the oxycodone to fentanyl for postoperative pain relief in patients undergoing total hip arthroplasty (replacement). Therefore, we established this randomized study to compare the efficacy of oxycodone and fentanyl for relief of postoperative pain after total hip arthroplasty (replacement).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 28-62 years old,
- •Both genders, American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for elective total hip surgery.
排除标准
- •Patients with history of any kind of drug allergy.
- •drug abuse.
- •psychological or other emotional problems,
- •renal and hepatic chronic disease.
研究组 & 干预措施
Group fentanyl
Patients will receive 50 ug of fentanyl 20 min before the end of surgery.
干预措施: propofol, rocuronium and fentanyl (Drug)
Group oxycodone
Patients will receive 4 mg of oxycodone 20 min before the end of surgery.
干预措施: propofol, rocuronium and fentanyl (Drug)
结局指标
主要结局
Improving A post-anesthesia care unit (PACU) pain score.
时间窗: 48 hours
The visual analogue scale (VAS) will be used for assessment of postoperative pain severity (0 for no pain and 10 for the most severe pain).
次要结局
- Hemodynamics(48 hours)
- Postoperative side effects(48 hours)
- Postoperative consumption of opioid(48 hours postoperatively)
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University