Liposomal Bupivacaine for Peripheral Nerve Blockade: A Randomized, Controlled, Crossover, Triple-blinded Pharmacodynamic Study in Volunteers.

IF 9.1 1区 医学 Q1 ANESTHESIOLOGY
Markus Zadrazil, Peter Marhofer, Philipp Opfermann, Werner Schmid, Daniela Marhofer, Mira Zeilberger, Lena Pracher, Markus Zeitlinger
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引用次数: 0

Abstract

Background: Little is known about the pharmacodynamic characteristics of liposomal bupivacaine. Hypothesizing that they would not identify pharmacodynamic differences from plain bupivacaine during the initial period after administration, but would find better long-term pharmacodynamic characteristics, the authors designed a randomized, controlled, triple-blinded, single-center study in volunteers.

Methods: Volunteers aged 18 to 55 yr (body mass index, 18 to 35 kg/m2) received two ulnar nerve blocks under ultrasound guidance. Using a crossover design with a washout phase of 36 days or more, one block was performed with liposomal and one with plain bupivacaine. Which came first was determined by randomization. Sensory data were collected by pinprick testing and motor data by thumb adduction, either way in comparison with the contralateral arm. Endpoints included success, time to onset, and duration of blockade. Residual efficacy was assessed by the volunteers keeping a diary. Statistical analysis included Wilcoxon signed-rank and exact McNemar's tests, as well as a generalized estimation equation model.

Results: Successful sensory blockade was noted in 8 of 25 volunteers (32%) after liposomal and in 25 of 25 (100%) after plain bupivacaine (P < 0.0001). Significant differences emerged for time to onset, defined as 0% response to pinpricking in four of five hypothenar supply areas (P < 0.0001), and for time from onset to 80% or 20% in one of five areas (P < 0.001; P < 0.001). Carryover effects due to the randomized sequencing were unlikely (estimate, -0.6286; sequence effect, 0.8772; P = 0.474). Self-assessment greater than 3.5 days did reveal, for liposomal bupivacaine only, intermittent but unpredictable episodes of residual sensory blockade.

Conclusions: The results show that liposomal bupivacaine is not a suitable "sole" drug for intraoperative regional anesthesia. Findings of its limited long-term efficacy add to existing evidence that a moderate effect, at best, should be expected on postoperative pain therapy.

Editor’s perspective:

用于外周神经阻滞的脂质体布比卡因:一项针对志愿者的随机、对照、交叉、三重对照药效学研究。
背景:人们对脂质体布比卡因的药效学特性知之甚少。我们假设,在用药后的最初阶段,我们不会发现与普通布比卡因的药效学差异,但会发现更好的长期药效学特征,因此我们设计了一项在志愿者中进行的随机、对照、三盲、单中心研究:年龄在 18 至 55 岁之间的志愿者(体重指数:18 至 35 kg/m²)在超声引导下接受了两次尺神经阻滞治疗。采用交叉设计,冲洗期≥ 36 天,一次用脂质体阻滞,一次用普通布比卡因阻滞。先用哪一种由随机决定。感觉数据通过针刺测试收集,运动数据通过拇指内收收集,无论哪种方式都要与对侧手臂进行比较。终点包括成功率、起效时间和阻滞持续时间。剩余疗效由志愿者记日记进行评估。统计分析包括 Wilcoxon 符号秩检验、精确 McNemar 检验以及广义估计方程模型:结果:8/25(32%)名志愿者使用脂质体后成功阻断了感觉,25/25(100%)名志愿者使用普通布比卡因后成功阻断了感觉(P < 0.0001)。在 4/5 个腓肠肌下供血区,起效时间定义为针刺反应为 0%(P < 0.0001);在 1/5 个供血区,起效时间定义为针刺反应为 80% 或 20%(P < 0.001; 0.001)。由于随机排序而产生的带入效应不太可能发生(估计值:-0.6286;SE:0.8772;P = 0.474)。3.5天的自我评估显示,只有脂质体布比卡因出现了间歇性但不可预测的残余感觉阻滞:我们的研究结果表明,脂质体布比卡因并不是术中区域麻醉的 "唯一 "药物。我们的研究结果表明,脂质体布比卡因并不是术中区域麻醉的 "唯一 "药物,其有限的长期疗效补充了现有的证据,即对术后疼痛治疗最多只能起到适度的效果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Anesthesiology
Anesthesiology 医学-麻醉学
CiteScore
10.40
自引率
5.70%
发文量
542
审稿时长
3-6 weeks
期刊介绍: With its establishment in 1940, Anesthesiology has emerged as a prominent leader in the field of anesthesiology, encompassing perioperative, critical care, and pain medicine. As the esteemed journal of the American Society of Anesthesiologists, Anesthesiology operates independently with full editorial freedom. Its distinguished Editorial Board, comprising renowned professionals from across the globe, drives the advancement of the specialty by presenting innovative research through immediate open access to select articles and granting free access to all published articles after a six-month period. Furthermore, Anesthesiology actively promotes groundbreaking studies through an influential press release program. The journal's unwavering commitment lies in the dissemination of exemplary work that enhances clinical practice and revolutionizes the practice of medicine within our discipline.
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