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近期发生周围神经性疼痛的参与者接受利多卡因连续输注后的长期疼痛结局:一项先导性双盲、随机、安慰剂对照试验。

Long-term pain outcomes after serial lidocaine infusion in participants with recent onset of peripheral neuropathic pain: A pilot double-blind, randomized, placebo-controlled trial.

机构信息

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Medicine (Baltimore). 2024 May 24;103(21):e38253. doi: 10.1097/MD.0000000000038253.

Abstract

BACKGROUND

This study investigated the outcomes up to 12 weeks after serial lidocaine infusion for early-onset peripheral neuropathic pain.

METHODS

This pilot double-blind, randomized, 2-arm placebo-controlled trial recruited 50 participants with onset of peripheral neuropathic pain within the past 6 months and randomized them to either receive lidocaine (3 mg/kg) in normal saline (50 mL) intravenous infusion over 1 hour (lidocaine group) once a week for 4 weeks or 50 mL of normal saline infusion (placebo group) once a week for 4 weeks. Twenty-nine participants completed the protocol; 15 participants were assigned to the lidocaine group and 14 to the placebo group. The outcomes were pain intensity assessed using a numerical rating scale (NRS), quality of life assessed using EuroQol-Five Dimensions-Five Levels questionnaire (EQ-5D-5L), psychological function using the Thai version of the 21-item Depression Anxiety Stress Scales (DASS-21), pain medication use, and adverse effects, all assessed at baseline (BL) and again at 4, 8, and 12 weeks following randomization.

RESULTS

The reported tramadol use at 8 and 12 weeks following the first infusion was significantly lower in the lidocaine group (P = .023). No other significant between-group differences were observed at any time point or for any other outcome, and no serious adverse events were observed.

CONCLUSION

Multiple lidocaine infusions of 3 mg/kg once a week for 4 weeks in participants with recent onset of peripheral neuropathic pain demonstrated no significant benefits in pain intensity, quality of life, or psychological outcomes. At most, this treatment may result in less tramadol use.

摘要

背景

本研究调查了早期外周神经性疼痛患者连续利多卡因输注后 12 周的结局。

方法

这是一项前瞻性、双盲、随机、2 臂安慰剂对照试验,招募了 50 名发病时间在过去 6 个月内的外周神经性疼痛患者,将他们随机分为利多卡因(3mg/kg)生理盐水(50ml)静脉输注组(利多卡因组),每周 1 次,持续 4 周,或生理盐水(安慰剂组)50ml 输注组,每周 1 次,持续 4 周。29 名参与者完成了方案;15 名参与者被分配到利多卡因组,14 名参与者被分配到安慰剂组。结局评估包括使用数字评分量表(NRS)评估疼痛强度、使用 EuroQol-Five Dimensions-Five Levels 问卷(EQ-5D-5L)评估生活质量、使用泰国版 21 项抑郁焦虑应激量表(DASS-21)评估心理功能、疼痛药物使用和不良反应,所有评估均在基线(BL)和随机分组后第 4、8 和 12 周进行。

结果

报告显示,在第一次输注后 8 周和 12 周时,利多卡因组曲马多的使用明显减少(P=0.023)。在任何时间点或任何其他结局上均未观察到其他显著的组间差异,也未观察到严重不良事件。

结论

在近期发病的外周神经性疼痛患者中,每周 1 次、连续 4 周输注 3mg/kg 利多卡因,在疼痛强度、生活质量或心理结局方面均未显示出显著益处。最多可能导致曲马多使用减少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fc1/11124726/eeb7edc8fad9/medi-103-e38253-g001.jpg

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