随机临床试验中的主要结果和预期效果大小,评估外围神经阻塞的附加物:范围审查
Sarah Sofie Bitsch Flyger1, Sandra Sorenson1, Lasse Pingel1
1Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Acta anaesthesiologica Scandinavica
|July 9, 2024
概括
这一对对外围神经阻断的随机试验的综述发现止痛的持续时间是最常见的初级结果. 标准化结果和效果大小可以改善未来对这些麻醉辅助剂的研究.
科学领域:
- 麻醉学 麻醉学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 随机临床试验 (RCT) 表明,局部麻醉剂在外围神经块中的附加剂具有延长作用.
- 主要结果的选择和预期效果的大小显著影响了RCT结果的临床相关性.
- 本范围审查提供了一个概述常用的结果和预期的效果大小在RCTs对外围神经阻塞附加.
研究的目的:
- 概述经常用于评估外围神经阻塞的附加剂的RCT中使用的初级结果.
- 识别和总结用于这些试验的样本大小估计的预期效应大小.
- 通过建议标准化结果和效果大小以实现方法同质性,为未来的研究提供信息.
主要方法:
- 在 MEDLINE,Embase 和 CENTRAL 搜索了主要麻醉学期刊上发表的关于外周神经阻断附加的 RCT.
- 包括对一次性超声波导向外围神经块的附加剂进行评估的RCT.
- 主要结果:选择主要结果和预期效果大小用于样本大小估计;次要结果:结果评估者,样本大小计算报告和结果意义.
主要成果:
- 包括59个RCT. 最常见的初级结局是镇痛的持续时间 (59%的试验).
- 辅助与安慰剂的中位预期效果大小:240分钟 (30%的增加). 对于辅助与主动比较器:210分钟 (17%的增长).
- 在78%的试验中报告了充分的样本大小计算. 76%的人报告了统计学上显著的初级结果,22%的人没有达到预期的效果大小.
结论:
- 疼痛缓解的持续时间是对外围神经阻断的试验的主要主要结果.
- 报告的预期效应大小为未来的研究设计提供了基准.
- 标准化结果和效果大小可以提高未来对外围神经阻塞附加剂的RCT的方法一致性.
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