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脂质体布比卡因在控制儿童脊柱手术后的术后疼痛方面既安全又有效:一项对照队列研究。

Liposomal Bupivacaine Is Both Safe and Effective in Controlling Postoperative Pain After Spinal Surgery in Children: A Controlled Cohort Study.

机构信息

Departments of Orthopaedic Surgery.

Anesthesiology.

出版信息

Clin Spine Surg. 2020 Dec;33(10):E533-E538. doi: 10.1097/BSD.0000000000000996.

DOI:10.1097/BSD.0000000000000996
PMID:32324672
Abstract

STUDY DESIGN

Retrospective comparative cohort study.

OBJECTIVE

To evaluate: (1) pain relief efficacy; (2) opioid consumption; (3) length of stay (LOS); (4) discharge disposition (DD); and (5) safety and adverse effects of liposomal bupivacaine (LB) in pediatric patients who underwent spinal deformity correction.

SUMMARY OF BACKGROUND DATA

LB is a long-acting, locally injectable anesthetic. Previous orthopedic studies investigating its use have been limited to adult patients. The use of LB as part of postoperative pain management in pediatric patients undergoing spine deformity correction surgery is yet to be evaluated.

MATERIALS AND METHODS

A total of 195 patients that received LB as part of their postoperative pain management regimen were compared with 128 patients who received standard pain management without LB. Pain intensity, opioid consumption, LOS, and DD were recorded. Potential LB-related complications were reported as frequencies and statistically compared for superiority. Noninferiority tests were performed using the Farrington-Manning score test. Multivariate tests based on generalized estimating equations were performed to determine the common and average treatment effects. Odds ratios (OR) with 95% confidence intervals (CI) were calculated.

RESULTS

The LB cohort demonstrated lower pain scores [postoperative day 1 (POD 1)-median=2, interquartile range (IQR)=(0-5) vs. 5 (2.5-7); POD 2-3 (0-5) vs. 4 (3-6); P<0.001], lower overall opioid consumption (78.2 vs. 129 morphine milligram equivalents; P=0.0001) and consistently from POD 0 to 3 (mean differences; 7.47, 9.04, 17.2, and 17.3 morphine milligram equivalents, respectively; P<0.01), shorter LOS (median=3 d, IQR=3-4 vs. 4 d, IQR=4-6; P<0.001), and similar to-home DD (98% vs. 97%). Complications were similar among the cohorts in superiority and 10% noninferiority analyses. Patients in the LB cohort had lower odds for complications (odds ratio=0.77; 95% CI, 0.64-0.93; P=0.009 and 0.67; 95% CI, 0.50-0.90; P=0.008).

CONCLUSIONS

This study demonstrated the safety and efficacy of LB when added to the current multimodal postoperative pain management regimens after pediatric spinal surgery.

LEVEL OF EVIDENCE

Level III.

摘要

研究设计

回顾性对比队列研究。

目的

评估:(1)止痛效果;(2)阿片类药物的使用量;(3)住院时间(LOS);(4)出院去向(DD);(5)鞘内注射布比卡因脂质体(LB)在接受脊柱畸形矫正的儿科患者中的安全性和不良反应。

背景资料概要

LB 是一种长效、局部注射用麻醉剂。先前关于其使用的骨科研究仅限于成年患者。LB 作为儿科患者脊柱畸形矫正手术后术后疼痛管理的一部分的使用情况尚未得到评估。

材料和方法

将接受 LB 作为术后疼痛管理方案一部分的 195 例患者与 128 例接受标准疼痛管理而未接受 LB 的患者进行比较。记录疼痛强度、阿片类药物的使用量、LOS 和 DD。报告潜在的 LB 相关并发症的频率,并进行统计学比较以确定优势。使用 Farrington-Manning 评分检验进行非劣效性检验。基于广义估计方程的多变量检验用于确定常见和平均治疗效果。计算优势比(OR)及其 95%置信区间(CI)。

结果

LB 组的疼痛评分较低[术后第 1 天(POD 1)-中位数=2,四分位距(IQR)=(0-5)比 5(2.5-7);POD 2-3(0-5)比 4(3-6);P<0.001],总阿片类药物使用量较低(78.2 与 129 吗啡毫克当量;P=0.0001),从 POD 0 到 3 持续较低(平均差异分别为 7.47、9.04、17.2 和 17.3 吗啡毫克当量;P<0.01),住院时间较短(中位数=3 天,IQR=3-4 比 4 天,IQR=4-6;P<0.001),家庭 DD 相似(98%比 97%)。在优势和 10%非劣效性分析中,两组的并发症相似。LB 组患者的并发症发生率较低(优势比=0.77;95%CI,0.64-0.93;P=0.009 和 0.67;95%CI,0.50-0.90;P=0.008)。

结论

本研究表明 LB 加入到儿科脊柱手术后当前的多模式术后疼痛管理方案中是安全有效的。

证据水平

III 级。

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