Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, California, USA
Orthopedic Surgery, University of California San Francisco, San Francisco, California, USA.
BMJ Open. 2022 Jun 6;12(6):e059416. doi: 10.1136/bmjopen-2021-059416.
Postoperative delirium is a frequent adverse event following elective non-cardiac surgery. The occurrence of delirium increases the risk of functional impairment, placement to facilities other than home after discharge, cognitive impairment at discharge, as well as in-hospital and possibly long-term mortality. Unfortunately, there is a dearth of effective strategies to minimise the risk from modifiable risk factors, including postoperative pain control and the analgesic regimen. Use of potent opioids, currently the backbone of postoperative pain control, alters cognition and has been associated with an increased risk of postoperative delirium. Literature supports the intraoperative use of lidocaine infusions to decrease postoperative opioid requirements, however, whether the use of postoperative lidocaine infusions is associated with lower opioid requirements and subsequently a reduction in postoperative delirium has not been investigated.
The Lidocaine Infusion for the Management of Postoperative Pain and Delirium trial is a randomised, double-blinded study of a postoperative 48-hour infusion of lidocaine at 1.33 mg/kg/hour versus placebo in older patients undergoing major reconstructive spinal surgery at the University of California, San Francisco. Our primary outcome is incident delirium measured daily by the Confusion Assessment Method in the first three postoperative days. Secondary outcomes include delirium severity, changes in cognition, pain scores, opioid use, incidence of opioid related side effects and functional benefits including time to discharge and improved recovery from surgery. Lidocaine safety will be assessed with daily screening questionnaires and lidocaine plasma levels.
This study protocol has been approved by the ethics board at the University of California, San Francisco. The results of this study will be published in a peer-review journal and presented at national conferences as poster or oral presentations. Participants wishing to know the results of this study will be contacted directly on data publication.
NCT05010148.
术后谵妄是择期非心脏手术后常见的不良事件。谵妄的发生增加了功能障碍的风险、出院后安置在家庭以外的场所、出院时认知障碍，以及院内和可能的长期死亡率。不幸的是，目前缺乏有效的策略来降低可改变的风险因素的风险，包括术后疼痛控制和镇痛方案。目前术后疼痛控制的骨干是使用强效阿片类药物，它们会改变认知，并与术后谵妄风险增加相关。文献支持术中使用利多卡因输注来减少术后阿片类药物的需求，然而，术后使用利多卡因输注是否与较低的阿片类药物需求相关，随后是否降低术后谵妄尚未得到研究。
利多卡因输注治疗术后疼痛和谵妄试验是一项在加利福尼亚大学旧金山分校进行的大型脊柱重建手术的老年患者中，在术后 48 小时内以 1.33mg/kg/h 的速度输注利多卡因与安慰剂的随机、双盲研究。我们的主要结局是在术后前三天每天通过意识模糊评估法测量术后谵妄的发生率。次要结局包括谵妄严重程度、认知变化、疼痛评分、阿片类药物使用、阿片类药物相关副作用的发生率以及功能获益，包括出院时间和手术恢复的改善。将通过每日筛查问卷和利多卡因血浆水平评估利多卡因的安全性。
本研究方案已获得加利福尼亚大学旧金山分校伦理委员会的批准。该研究的结果将在同行评议的期刊上发表，并以海报或口头报告的形式在全国会议上展示。希望了解该研究结果的参与者将在数据发表时直接联系。
NCT05010148。
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