Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: Does it Help to Relieve Postoperative Pain?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- efficacy
研究概览
简要总结
To prove pregabalin's efficacy and safety in Thai patients scheduled for arthroscopic ACL reconstruction
详细描述
Only eligible patients with willingness to join this study are included. Eligible patients are those aged 18-65 years of either sex, American Society of Anesthesiologists (ASA) physical status I & II, and body mass index (BMI) between 16-35. The exclusion criteria are patients who are allergic to pregabalin, with impaired hepatic and renal functions, alcohol or substance abuse, chronic pain (except pain in the knee joint) or daily intake of analgesics, uncontrolled medical disease (hypertension and diabetes mellitus) and inability to operate patient-controlled analgesia (PCA) device.
Data analysis
- Student t-test for continuous data with normal distribution
- Mann-Whitney U test for continuous data with non-normal distribution
- Chi-square test for categorical data
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients are those aged 18-65 years of either sex,
- •American Society of Anesthesiologists (ASA) physical status I & II, and body mass index (BMI) between 16-35.
排除标准
- •patients who are allergic to pregabalin,
- •impaired hepatic and renal functions,
- •alcohol or substance abuse,
- •chronic pain (except pain in the knee joint) or daily intake of analgesics, uncontrolled medical disease (hypertension and diabetes mellitus)
- •inability to operate patient-controlled analgesia (PCA) device
研究组 & 干预措施
Pregabalin
75 mg po 2 hrs before surgery
干预措施: Pregabalin (Drug)
结局指标
主要结局
efficacy
时间窗: August 2009 - January 2011
efficacy of postoperative pain management
次要结局
- safety(August 2009 - January 2011)