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随机、双盲、安慰剂对照试验,使用 5%利多卡因贴剂治疗创伤性肋骨骨折。

Randomized, double-blind, placebo-controlled trial using lidocaine patch 5% in traumatic rib fractures.

机构信息

Michigan State University/Grand Rapids Medical Education and Research Center, Grand Rapids, MI, USA.

出版信息

J Am Coll Surg. 2010 Feb;210(2):205-9. doi: 10.1016/j.jamcollsurg.2009.10.020. Epub 2009 Dec 24.

DOI:10.1016/j.jamcollsurg.2009.10.020
PMID:20113941
Abstract

BACKGROUND

The lidocaine patch 5% was developed to treat postherpetic neuralgia. Anecdotal experience at our institution suggests the lidocaine patch 5% decreases narcotic usage in patients with traumatic rib fractures. This trial was developed to define the patch's efficacy.

STUDY DESIGN

Patients with rib fractures admitted to the trauma service at our Level I trauma center were enrolled and randomized in a 1 to 1 double-blind manner to receive a lidocaine patch 5% or placebo patch. Fifty-eight patients who met the inclusion criteria were enrolled from January 2007 to August 2008. Demographic and clinical information were recorded. The primary outcomes variable was total narcotic use, analyzed using the 1-tailed Mann-Whitney test. The secondary outcomes variables included non-narcotic pain medication, average pain score, pulmonary complications, and length of stay. Significance was defined based on a 1-sided test for the primary outcome and 2-sided tests for other comparisons, at p < 0.05.

RESULTS

Thirty-three patients received the lidocaine patch 5% and 25 received the placebo patch. There were no significant differences in age, number of rib fractures, gender, trauma mechanism, preinjury lung disease, smoking history, percent of current smokers, and need for placement of chest tube between the lidocaine patch 5% and placebo groups. There was no difference between the lidocaine patch 5% and placebo groups, respectively, with regard to total IV narcotic usage: median, 0.23 units versus 0.26 units; total oral narcotics: median, 4 units versus 7 units; pain score: 5.6 +/- 0.4 versus 6.0 +/- 0.3 (mean +/- SEM); length of stay: 7.8 +/- 1.1 versus 6.2 +/- 0.7; or percentage of patients with pulmonary complications: 72.7% versus 72.0%.

CONCLUSIONS

The lidocaine patch 5% does not significantly improve pain control in polytrauma patients with traumatic rib fractures.

摘要

背景

5%利多卡因贴剂是为治疗疱疹后神经痛而开发的。我们机构的一些经验表明,5%利多卡因贴剂可减少创伤性肋骨骨折患者对麻醉性镇痛药的使用。本试验旨在确定该贴剂的疗效。

研究设计

我们的一级创伤中心创伤科收治的肋骨骨折患者入组并以 1:1 的比例随机接受 5%利多卡因贴剂或安慰剂贴剂,采用双盲法。2007 年 1 月至 2008 年 8 月共纳入符合纳入标准的 58 例患者。记录患者的人口统计学和临床资料。主要结局变量为总麻醉性镇痛药用量,采用单侧 Mann-Whitney 检验进行分析。次要结局变量包括非麻醉性镇痛药、平均疼痛评分、肺部并发症和住院时间。主要结局变量采用单侧检验,其他比较采用双侧检验,p 值 < 0.05 为差异有统计学意义。

结果

33 例患者接受 5%利多卡因贴剂,25 例患者接受安慰剂贴剂。两组患者的年龄、肋骨骨折数、性别、创伤机制、受伤前肺部疾病、吸烟史、当前吸烟者比例以及是否需要放置胸腔引流管等方面差异均无统计学意义。5%利多卡因贴剂组与安慰剂组的 IV 麻醉性镇痛药总用量分别为:中位数 0.23 单位对 0.26 单位;口服麻醉性镇痛药总量分别为:中位数 4 单位对 7 单位;疼痛评分分别为:5.6±0.4 对 6.0±0.3(均值±SEM);住院时间分别为:7.8±1.1 对 6.2±0.7;以及肺部并发症发生率分别为:72.7%对 72.0%。

结论

5%利多卡因贴剂不能显著改善创伤性肋骨骨折多发伤患者的疼痛控制。

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