RESPONSE TO IV LIDOCAINE PREDICT FAVORABLE RESPONSE TO ORAL MEXILETIE

对静脉注射利多卡因的反应预示对口服美西乐的良好反应

• 批准号: 6218263
• 负责人: SRINIVASA N. RAJA
• 金额: $ 0.23万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6218263
• 关键词: amputation; analgesics; clinical research; clinical trials; drug screening /evaluation; human subject; human therapy evaluation; intravenous administration; lidocaine; mexiletine

Phantom Limb pain and stump pain are common post-amputation sequela. Most recent studies estimate 50-75% of amputees suffer from phantom pain early after amputation. Persistent phantom pain is difficult to treat and often worsens over time. Stump pain is less common and often decreases with time. we determined the efficacy of intravenous lidocaine and morphine infusions as compared to placebo on phantom and stump pain after amputation of extremities using a double-blind randomized protocol. Six patients (2 F and 4 M) were enrolled between 12/01/97 and 11/30/98 following approval by the institutional investigational review board. Exclusion criteria included age <18 or >90, cardiac conduction defects, myocardial infarction within 6 months, severe pulmonary, hepatic, or hematologic disease, and history of seizures, dementia, or encephalopathy. In a double blind fashion, an intravenous bolus followed by an infusion of lidocaine (5mg/kg), or morphine (0.25mg/kg), or diphenhydramine (25mg) were administered over 30 minutes. Phantom and/ or stump pain, and pain evoked by a brass probe over the sensitive region of the stump were recorded at 5 minute intervals starting 30 minutes prior to bolus dose and continued 30 minutes after the end of infusion. The drun-induced change in pain scores were compared to preinfusion baseline pain scores. Phantom pain scores were decreased by lidocaine (range = 4.50% - 68.40%) in all 5 patients tested, and by morphine (range = 1.46% - 39%) in 4 out of 5 patients tested. One of the patients did not respond to morphine infusion. Only 2 out of 5 patients tested responded to diphenhydramine placebo infusion (range = 2%-4.77%). Stump pain scores were decreased by lidocaine (range = 23.50% - 100%), and by morphine (range = 13.76% - 67.63%) in all 6 patients tested. Only 3 out of 6 patients tested reported stump pain relief (ranges = 0.49% - 10.75%) to diphenhydramine placebo infusion.

幻肢痛和残肢痛是截肢后常见的后遗症。 最近的研究估计，50-75% 的截肢者在截肢后不久就会出现幻痛。 持续性幻痛很难治疗，并且通常会随着时间的推移而恶化。 残肢疼痛不太常见，并且通常会随着时间的推移而减轻。 我们使用双盲随机方案确定了静脉注射利多卡因和吗啡与安慰剂相比对四肢截肢后幻肢痛和残肢痛的疗效。经机构研究审查委员会批准后，6 名患者（2 F 和 4 M）于 97 年 1 月 12 日至 98 年 11 月 30 日期间入组。排除标准包括年龄<18岁或>90岁、心脏传导缺陷、6个月内心肌梗死、严重肺部、肝脏或血液系统疾病，以及癫痫、痴呆或脑病病史。以双盲方式，在 30 分钟内静脉推注，然后输注利多卡因 (5mg/kg)、吗啡 (0.25mg/kg) 或苯海拉明 (25mg)。 从推注剂量前30分钟开始并持续输注结束后30分钟，每隔5分钟记录幻痛和/或残肢痛以及由黄铜探针在残肢敏感区域引起的疼痛。 将药物引起的疼痛评分变化与输注前基线疼痛评分进行比较。利多卡因（范围 = 4.50% - 68.40%）使所有 5 名接受测试的患者的幻痛评分降低，吗啡（范围 = 1.46% - 39%）使 5 名接受测试的患者中有 4 人的幻痛评分降低。 其中一名患者对吗啡输注没有反应。接受测试的 5 名患者中，只有 2 名对苯海拉明安慰剂输注有反应（范围 = 2%-4.77%）。 在所有 6 名接受测试的患者中，利多卡因（范围 = 23.50% - 100%）和吗啡（范围 = 13.76% - 67.63%）均降低了残肢疼痛评分。 接受测试的 6 名患者中，只有 3 名报告苯海拉明安慰剂输注可缓解残肢疼痛（范围 = 0.49% - 10.75%）。