利多卡因治疗神经性癌症疼痛 (LiCPain):试点随机对照试验
Jessica T Lee1, Melanie R Lovell2, Megan Ritchie3
1Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) (J.T.L., B.F., J.L.P., R.C., M.A.), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia; Concord Clinical School (J.T.L., M.R., A.L., G.A., D.M.), University of Sydney, Concord, New South Wales, Australia.
这项试点研究发现,对神经病性癌症疼痛进行连续皮下输注利多卡因的试验是可行的. 进一步的研究可以探索更高的利多卡因剂量,以改善疼痛管理.
科学领域:
- 抚慰性护理是一种缓解性护理.
- 疼痛管理 疼痛管理
- 临床药理学 临床药理学
背景情况:
- 连续皮下输注利多卡因用于神经病性癌症疼痛.
- 需要进行强大的临床试验来确认疗效和安全性.
研究的目的:
- 评估III期随机对照试验 (RCT) 持续皮下输注利多卡因与安慰剂的可行性.
- 评估在多站点试验中招募和保留神经性癌症疼痛患者的潜力.
主要方法:
- 患有神经性癌症疼痛的成年患者随机分配,在72小时内接受滴定连续皮下输注利多卡因或安慰剂.
- 剂量定位范围从1到2毫克/公斤/小时,上限为120毫克/小时.
- 通过招募率,药物完成和不良事件来评估可行性.
主要成果:
- 在54个月内招募了17名参与者,研究药物和手术的完成率为93%.
- 88%的参与者完成了整个72小时的研究药物治疗.
- 副作用是罕见的和轻度/中度的;在疼痛减轻方面没有观察到群体之间的显著差异.
结论:
- 这项试点研究表明,在神经病性癌症疼痛中进行连续皮下输注利多卡因的第三阶段RCT的可行性.
- 招募策略需要改进,更高的利多卡因剂量需要谨慎调查.
- 这些发现为临床实践和对皮下利多卡因输注的未来研究提供了信息.
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