Lidocaine Infusion for the Management of Postoperative Pain and Delirium (LIMPP): protocol for a randomised control trial.
Lidocaine Infusion for the Management of Postoperative Pain and Delirium (LIMPP): protocol for a randomised control trial.
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利多卡因输注治疗术后疼痛和谵妄（LIMPP）：一项随机对照试验方案。
DOI：
10.1136/bmjopen-2021-059416
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发表时间：
2022-06-06
期刊：
影响因子：
2.9
通讯作者：
Leung, Jacqueline M.
中科院分区：
文献类型：
--
作者：
Buren, Marc Alan;Theologis, Alekos;Zuraek, Ariadne;Behrends, Matthias;Clark, Aaron J.;Leung, Jacqueline M.
术后谵妄是选择性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、出院后安置到家庭以外的设施、出院时认知障碍以及住院和可能的长期死亡的风险。不幸的是，缺乏有效的策略来减少可改变的危险因素的风险，包括术后疼痛控制和镇痛方案。使用强效阿片类药物，目前是术后疼痛控制的支柱，改变认知，并与术后谵妄的风险增加有关。文献支持术中输注利多卡因减少术后阿片类药物需求，然而，术后输注利多卡因是否与降低阿片类药物需求以及随后减少术后谵妄相关尚未研究。利多卡因输注治疗术后疼痛和谵妄的试验是一项随机双盲研究，在加州大学旧金山分校接受重大脊柱重建手术的老年患者中，术后48小时输注1.33 mg/kg/小时的利多卡因与安慰剂相比。我们的主要结果是术后前三天每天用神志不清评估法测量的谵妄。次要结局包括谵妄严重程度、认知改变、疼痛评分、阿片类药物的使用、阿片类药物相关副作用的发生率和功能获益，包括出院时间和手术后恢复的改善。利多卡因安全性将通过每日筛查问卷和利多卡因血浆水平进行评估。本研究方案已获得加州大学旧金山分校伦理委员会的批准。这项研究的结果将发表在同行评审期刊上，并以海报或口头报告的形式在国家会议上发表。希望了解本研究结果的参与者将在数据发布时直接联系。NCT05010148。
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.
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影响因子：
8.8
作者：
Leung JM;Sands LP;Chen N;Ames C;Berven S;Bozic K;Burch S;Chou D;Covinsky K;Deviren V;Kinjo S;Kramer JH;Ries M;Tay B;Vail T;Weinstein P;Chang S;Meckler G;Newman S;Tsai T;Voss V;Youngblom E;Perioperative Medicine Research Group
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作者：
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5.7
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Lopez, Oscar L;Kuller, Lewis H
通讯作者：
Kuller, Lewis H
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