NCT03211728已完成不适用
Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Postoperative pain scores
研究概览
简要总结
The investigators hypothesize that perioperative oral administration of pregabalin would reduce postoperative pain and produce reduction in postoperative opioid consumption after anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2 groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same points.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 20-65 years
- •physical condition type I or II in ASA (American Society of Anesthesiology)
排除标准
- •patients of ASA classification 3 or more
- •with a history of cardiovascular or respiratory disease
- •dizziness or frequent headache
- •active alcohol or drug usage,
- •intake of any analgesics daily or 48 hours before surgery
- •impaired renal and/or hepatic function
研究组 & 干预措施
experimental group
Experimental
干预措施: pregabalin (Drug)
placebo group
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Postoperative pain scores
时间窗: 2 weeks after surgery
Visual analog scale (VAS) score = 0-100 mm
次要结局
- Opioid consumption(the first 48 hours after surgery)
研究者
研究点 (1)
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