Sorenson Sandra, Flyger Sarah Sofie Bitsch, Pingel Lasse, Karlsen Anders Peder Højer, Nørskov Anders Kehlet, Maagaard Mathias, Mathiesen Ole
Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Br J Anaesth. 2025 Feb;134(2):535-544. doi: 10.1016/j.bja.2024.09.029. Epub 2024 Dec 4.
Peripheral and truncal nerve blocks provide effective analgesia facilitating perioperative care. However, thresholds for clinically relevant effects remain undetermined and are left for clinicians to choose. These choices are fundamental for sample size calculations and interpretation of study results. This systematic scoping review aimed to create an overview of primary outcomes and anticipated effect sizes in randomised clinical trials assessing peripheral and truncal nerve blocks.
We searched Cochrane Library's CENTRAL, Medline, and Embase for randomised trials in English in 10 major anaesthesia journals investigating single-injection ultrasound-guided peripheral and truncal nerve blocks for adults undergoing surgery. The primary outcome was the anticipated effect sizes for primary outcomes. Secondary outcomes included reporting of sample size calculations and statistically significant primary outcomes below anticipated effect sizes.
The most frequently reported primary outcomes were postoperative pain, analgesic consumption, quality of recovery, mobilisation, and block performance. Median anticipated effect sizes were: 0-24 h opioid consumption: 9 mg i.v. morphine equivalents; pain at rest and during movement: 2 points on Numeric Rating Scale 0-10; quality of recovery: 10 points on Quality of Recovery-40 scale and 8 points on Quality of Recovery-15 scale. Adequate sample size calculations were reported in 85% (156/183) and 91% (29/32) of trials assessing continuous outcomes and dichotomous outcomes, respectively. Statistically significant primary outcomes failed to reach anticipated effect sizes in 24% (24/99) of trials, and only one trial addressed this disparity in the trial conclusion.
The presented outcomes and effect sizes from published trials on peripheral and truncal nerve block literature can be used in future trials to increase homogeneity in regional anaesthesia research.
外周和躯干神经阻滞可提供有效的镇痛，有助于围手术期护理。然而，临床相关效应的阈值尚未确定，留给临床医生自行选择。这些选择对于样本量计算和研究结果的解释至关重要。本系统综述旨在概述评估外周和躯干神经阻滞的随机临床试验中的主要结局和预期效应大小。
我们在Cochrane图书馆的CENTRAL、Medline和Embase中检索了10种主要麻醉学杂志上的英文随机试验，这些试验研究了接受手术的成人单次注射超声引导下的外周和躯干神经阻滞。主要结局是主要结局的预期效应大小。次要结局包括样本量计算的报告以及低于预期效应大小的具有统计学意义的主要结局。
最常报告的主要结局是术后疼痛、镇痛药物消耗、恢复质量、活动能力和阻滞效果。预期效应大小的中位数为：0 - 24小时阿片类药物消耗量：静脉注射吗啡当量9毫克；静息和运动时疼痛：数字评分量表0 - 10上2分；恢复质量：恢复质量-40量表上10分，恢复质量-15量表上8分。分别有85%（156/183）和91%（29/32）评估连续性结局和二分结局的试验报告了足够的样本量计算。在24%（24/99）的试验中，具有统计学意义的主要结局未达到预期效应大小，只有一项试验在试验结论中讨论了这种差异。
已发表的关于外周和躯干神经阻滞文献的试验中呈现的结局和效应大小可用于未来的试验，以提高区域麻醉研究的同质性。
