the Effect of Adding Pregabalin on the Onset and the Duration of Spinal Anesthesia and on the Postoperative Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- onset of spinal anaesthesia
研究概览
简要总结
the purpose of this study is to evaluate the effectiveness of administration of pregabalin 2 hours preoperatively on the onset and the duration of the spinal anesthesia in total knee arthroplasty and the role of pregabalin in postoperative analgesia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the ages of 40 and 70 years
- •height 155-170 cm
- •American Society of Anesthesiologists grade I or II .
- •patients underwent total knee arthroplasty under spinal anesthesia
排除标准
- •patients known to be allergic to any medicines.
- •patients had a history of drug or alcohol abuse.
- •patients were taking opioids or sedative medications,
- •patients Inability to communicate with investigators to evaluate the postoperative pain
- •patients were in need for postoperative ICU hospitalization .
- •patients had a history of psychiatric conditions.
- •Patients with a history of taking pregabalin or gabapentin .
研究组 & 干预措施
pregabalin group
Two hours before surgery, the pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery.
干预措施: Pregabalin 150mg (Drug)
placebo group
The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .
干预措施: Placebo (Drug)
结局指标
主要结局
onset of spinal anaesthesia
时间窗: three months
seventy participants undergoing elective total knee arthroplasty under spinal anesthesia half of them took placebo and the other half took 150 mg pregabalin two hours before the procedure and calculate the time from the base line to the onset of anesthesia. Our primary outcome is to assess the onset of spinal anesthesia. to detect the onset of spinal anaesthesia
次要结局
- recovery time(three months)
- motor block duration(three months)
- postoperative analgesia(three months.)
研究者
Ismail Mohammed
principal investigator
Ain Shams University