Abstract：
BACKGROUND: Prolonging effects of adjuncts to local anaesthetics in peripheral nerve blocks have been demonstrated in randomised clinical trials. The chosen primary outcome and anticipated effect size have major impact on the clinical relevance of results in these trials. This scoping review aims to provide an overview of frequently used outcomes and anticipated effect sizes in randomised trials on peripheral nerve block adjuncts.
METHODS: For our scoping review, we searched MEDLINE, Embase and CENTRAL for trials assessing effects of adjuncts for peripheral nerve blocks published in 10 major anaesthesia journals. We included randomised clinical trials assessing adjuncts for single-shot ultrasound-guided peripheral nerve blocks, regardless of the type of interventional adjunct and control group, local anaesthetic used and anatomical localization. Our primary outcome was the choice of primary outcomes and corresponding anticipated effect size used for sample size estimation. Secondary outcomes were assessor of primary outcomes, the reporting of sample size calculations and statistically significant and non-significant results related to the anticipated effect sizes.
RESULTS: Of 11,854 screened trials, we included 59. The most frequent primary outcome was duration of analgesia (35/59 trials, 59%) with absolute and relative median (interquartile range) anticipated effect sizes for adjunct versus placebo/no adjunct: 240 min (180-318) and 30% (25-40) and for adjunct versus active comparator: 210 min (180-308) and 17% (15-28). Adequate sample size calculations were reported in 78% of trials. Statistically significant results were reported for primary outcomes in 45/59 trials (76%), of which 22% did not reach the anticipated effect size.
CONCLUSIONS: The reported outcomes and associated anticipated effect sizes can be used in future trials on adjuncts for peripheral nerve blocks to increase methodological homogeneity.
METHODS: For our scoping review, we searched MEDLINE, Embase and CENTRAL for trials assessing effects of adjuncts for peripheral nerve blocks published in 10 major anaesthesia journals. We included randomised clinical trials assessing adjuncts for single-shot ultrasound-guided peripheral nerve blocks, regardless of the type of interventional adjunct and control group, local anaesthetic used and anatomical localization. Our primary outcome was the choice of primary outcomes and corresponding anticipated effect size used for sample size estimation. Secondary outcomes were assessor of primary outcomes, the reporting of sample size calculations and statistically significant and non-significant results related to the anticipated effect sizes.
RESULTS: Of 11,854 screened trials, we included 59. The most frequent primary outcome was duration of analgesia (35/59 trials, 59%) with absolute and relative median (interquartile range) anticipated effect sizes for adjunct versus placebo/no adjunct: 240 min (180-318) and 30% (25-40) and for adjunct versus active comparator: 210 min (180-308) and 17% (15-28). Adequate sample size calculations were reported in 78% of trials. Statistically significant results were reported for primary outcomes in 45/59 trials (76%), of which 22% did not reach the anticipated effect size.
CONCLUSIONS: The reported outcomes and associated anticipated effect sizes can be used in future trials on adjuncts for peripheral nerve blocks to increase methodological homogeneity.
摘要：
背景：在随机临床试验中已经证明了局部麻醉药在周围神经阻滞中的延长作用。选择的主要结果和预期效应大小对这些试验结果的临床相关性有重大影响。本范围审查旨在概述周围神经阻滞辅助治疗的随机试验中经常使用的结果和预期的效果大小。
方法：对于我们的范围审查，我们搜索了MEDLINE,Embase和CENTRAL用于评估附件对周围神经阻滞的影响的试验发表在10种主要麻醉期刊上。我们纳入了随机临床试验，评估单次超声引导的周围神经阻滞的附件，无论介入辅助组和对照组的类型，局部麻醉使用和解剖定位。我们的主要结果是选择主要结果和用于样本量估计的相应预期效应大小。次要结果是主要结果的评估者，报告样本量计算以及与预期效应大小相关的有统计学意义和无统计学意义的结果。
结果：在11,854项筛选试验中，我们包括59。最常见的主要结局是镇痛持续时间（35/59试验，59％）具有绝对和相对中位数（四分位数范围）的预期效应大小，用于辅助与安慰剂/无辅助：240分钟（180-318）和30％（25-40），用于辅助与主动比较：210分钟（180-308）和17％（15-28）。在78%的试验中报告了足够的样本量计算。在45/59项试验（76％）中，主要结局报告了具有统计学意义的结果，其中22%没有达到预期的效果大小。
结论：报告的结果和相关的预期效应大小可用于未来的周围神经阻滞辅助治疗试验，以提高方法学的一致性。
方法：对于我们的范围审查，我们搜索了MEDLINE,Embase和CENTRAL用于评估附件对周围神经阻滞的影响的试验发表在10种主要麻醉期刊上。我们纳入了随机临床试验，评估单次超声引导的周围神经阻滞的附件，无论介入辅助组和对照组的类型，局部麻醉使用和解剖定位。我们的主要结果是选择主要结果和用于样本量估计的相应预期效应大小。次要结果是主要结果的评估者，报告样本量计算以及与预期效应大小相关的有统计学意义和无统计学意义的结果。
结果：在11,854项筛选试验中，我们包括59。最常见的主要结局是镇痛持续时间（35/59试验，59％）具有绝对和相对中位数（四分位数范围）的预期效应大小，用于辅助与安慰剂/无辅助：240分钟（180-318）和30％（25-40），用于辅助与主动比较：210分钟（180-308）和17％（15-28）。在78%的试验中报告了足够的样本量计算。在45/59项试验（76％）中，主要结局报告了具有统计学意义的结果，其中22%没有达到预期的效果大小。
结论：报告的结果和相关的预期效应大小可用于未来的周围神经阻滞辅助治疗试验，以提高方法学的一致性。
