Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: Does it Help to Relieve Postoperative Pain?
研究概览
详细说明
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
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Songkhla
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Hatyai、Songkhla、泰国、90110
- Faculty of Medicine, Prince of Songkla University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：placebo
po 2 hrs before surgery
|
|
|
实验性的：Pregabalin
75 mg po 2 hrs before surgery
|
75 mg po 2 hrs before surgery
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
efficacy
大体时间：August 2009 - January 2011
|
efficacy of postoperative pain management
|
August 2009 - January 2011
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
safety
大体时间：August 2009 - January 2011
|
safety of pregabalin for postoperative pain management
|
August 2009 - January 2011
|
合作者和调查者
调查人员
- 首席研究员：Sasikaan Nimmaanrat, MD, MMed、Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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