Analgesic Efficacy and Safety of Peri-operative Pregabalin Following Radical Cystectomy, a Prospective,Randomized, Double-blinded, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- visual analogue scale (VAS) score
研究概览
简要总结
This study compares analgesic efficacy, and safety of three different doses of peri-operative pregabaline to placebo following radical cystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sixty patients between the ages of 18 and 60 years.
- •American Society of Anesthesiologists (ASA) I-II physical status.
- •undergoing radical cystectomy under general anesthesia.
排除标准
- •Patients with a history of drug or alcohol abuse.
- •patients with chronic pain or daily intake of analgesics.
- •uncontrolled diabetes mellitus.
- •uncontrolled hypertension.
- •atherosclerotic heart disease.
- •seizures.
- •impaired kidney or liver functions,
- •patients with body mass index ≥35 kg/m2, and whom
- •patients that could not control a patient controlled analgesia (PCA) device.
研究组 & 干预措施
Group I (placebo)
patients received placebo.
干预措施: placebo (Drug)
Group II (pregabaline 300 once)
patients received pregabalin 300 mg 2 hours preoperatively.
干预措施: pregabaline 300 mg once. (Drug)
Group III (pregabaline 300 twice)
patients received pregabalin 300 mg 2 hours preoperatively and 12 hours after the preoperative dose.
干预措施: pregabaline 300 mg twice. (Drug)
Group IV (pregabaline 600)
patients received pregabalin 600 mg 2 hours preoperatively
干预措施: pregabaline 600 mg once. (Drug)
结局指标
主要结局
visual analogue scale (VAS) score
时间窗: 24 hours postoperatively
analgesic efficacy of study drugs as represented by the VAS score of the patients in the first 24 hours.
postoperative opioid consumption
时间窗: 24 hours postoperatively
ability of study drugs to reduce the postoperative opioid analgesic consumption.
time to first request of opioid analgesia
时间窗: 24 hours postoperatively
ability of the study drugs to delay the request of rescue opioid analgesia.
次要结局
- Safety assessed by incidence of side effects(24 hours postoperatively)
研究者
Ahmad Mohammad Abd El-Rahman
Lecturer of anesthesia, icu, and pain management
Assiut University