Patel Amour B U, Bibawy Phillip P W M, Majeed Zehra, Gan Weng Liang, Ackland Gareth L
Translational Medicine and Therapeutics, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
BJA Open. 2022 Jun;2:None. doi: 10.1016/j.bjao.2022.100017.
Established or acquired loss of parasympathetic vagal tone is associated with complications, including pain, after noncardiac surgery. We describe a study protocol designed to test the hypothesis that transcutaneous auricular nerve stimulation may preserve efferent parasympathetic activity to reduce pain and morbidity after noncardiac surgery.
Participants aged >18 yr scheduled for urgent/elective orthopaedic surgery (=86) will be randomly allocated to bilateral transcutaneous auricular nerve stimulation or sham protocol for 50 min at the same time of day, before and 24 h after surgery. Holter monitoring, the analysis of which is masked to allocation, will quantify autonomic modulation of HR. The primary outcome will be pain, quantified by absolute changes in VAS 24 h after surgery following sham or stimulation. Secondary outcomes include presence or absence of >10 mm change in the 100 mm VAS (which defines a minimum clinically important change) and postoperative morbidity (Postoperative Morbidity Survey) before and 24 h after surgery. The relationship between the explanatory variable (HR variability), VAS, and morbidity will be examined using a multilevel (mixed-error component) regression model. Safety and complications of the intervention will also be recorded. The study was approved by the NHS Research Ethics Committee (21/LO/0272). As of 25 December 2021, 34/86 participants (mean [standard deviation] age: 48 [19] yr; 14 females [41.2%]) have been recruited, with complete collection of Holter data.
This phase 2b study will explore whether noninvasive autonomic neuromodulation may reduce pain or morbidity using trans-auricular vagus nerve stimulation, providing proof-of-concept data for a non-pharmacological, generalisable approach to improve perioperative outcomes.
Researchregistry7566.
在非心脏手术中，已确立的或获得性的副交感迷走神经张力丧失与包括疼痛在内的并发症相关。我们描述了一项研究方案，旨在检验经皮耳神经刺激可能保留传出性副交感神经活动以减轻非心脏手术后疼痛和发病率的假设。
计划进行紧急/择期骨科手术（n = 86）且年龄大于18岁的参与者将被随机分配至双侧经皮耳神经刺激组或假手术组，在手术前和术后24小时的同一天同一时间进行50分钟的干预。动态心电图监测（其分析对分组情况设盲）将量化心率的自主调节。主要结局将是疼痛，通过假手术或刺激后术后24小时视觉模拟评分（VAS）的绝对变化来量化。次要结局包括100毫米VAS中是否出现大于10毫米的变化（这定义了最小临床重要变化）以及手术前和术后24小时的术后发病率（术后发病率调查）。将使用多水平（混合误差成分）回归模型检查解释变量（心率变异性）、VAS和发病率之间的关系。还将记录干预措施的安全性和并发症。该研究已获得英国国家医疗服务体系研究伦理委员会批准（21/LO/0272）。截至2021年12月25日，已招募34/86名参与者（平均[标准差]年龄：48 [19]岁；14名女性[41.2%]），已完整收集动态心电图数据。
这项2b期研究将探索非侵入性自主神经调节是否可通过经耳迷走神经刺激减轻疼痛或发病率，为改善围手术期结局的非药物、可推广方法提供概念验证数据。
Researchregistry7566。
