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超声引导下脂质体布比卡因与非脂质体布比卡因用于儿童Nuss手术后疼痛控制的比较:一项随机临床试验

Ultrasound-guided paravertebral block with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after the Nuss procedure in children: A randomized clinical trial.

作者信息

Wu Lei, Wei Si Wei, Chen Zheng, Jiang Li Dan, Qu Shuang Quan, Du Zhen

机构信息

Department of Anesthesiology, the Affiliated Children's Hospital of Xiangya School of Medicine, Central South University (Hunan Children's Hospital), Changsha, China.

Department of Anesthesiology, the Affiliated Children's Hospital of Xiangya School of Medicine, Central South University (Hunan Children's Hospital), Changsha, China.

出版信息

J Clin Anesth. 2025 Sep;106:111953. doi: 10.1016/j.jclinane.2025.111953. Epub 2025 Aug 5.

Abstract

STUDY OBJECTIVE

Minimally invasive repair of pectus excavatum (Nuss procedure) is associated with significant postoperative pain and high-dose opioid consumption. Liposomal bupivacaine (LB), as an ultra-long-acting local anesthetic, has been extensively studied for perioperative analgesia. However, data regarding the effects of LB on postoperative pain in children undergoing the Nuss procedure remain limited. The aim of this study was to evaluate the ability of LB to reduce postoperative opioid use among children undergoing the Nuss procedure.

DESIGN

Randomized controlled trial.

SETTING

Operating room.

PATIENTS

Children aged 6-18 years who were scheduled for elective Nuss procedures.

INTERVENTIONS

Patients were randomly assigned to receive ultrasound-guided paravertebral block with either LB or non-liposomal bupivacaine (nLB) after anesthesia induction.

MEASUREMENTS

The primary outcome was the consumption of morphine equivalent during the first 72 h after surgery. The secondary endpoints included the maximum Numerical Rating Scale (NRS) pain score within 72 h, incidence of moderate-to-severe pain within 72 h, incidence of rebound pain within 72 h, NRS sleep score at 3 days, incidence of postoperative nausea and vomiting, length of hospital stay after surgery, and time to first ambulation after the operation.

MAIN RESULTS

A total of 109 subjects were included in the intention-to-treat analysis. Within 72 h after surgery, the morphine equivalent consumption in the LB group was reduced by about 23 % compared with the nLB group (median difference: 23.1 mg; P = 0.023). The incidence of rebound pain was significantly lower in the LB group than in the nLB group (13.0 % [7/54] vs. 29.1 % [16/55], relative risk 0.46; 95 % CI: 0.20 0.96; P = 0.039). Subjective sleep quality was better in the LB group than in the nLB group on the second and third nights after surgery (median difference: -1 point; P = 0.005 and P = 0.016). The incidence of adverse events was similar in both groups, and no patients experienced severe adverse events during the study period.

CONCLUSIONS

Paravertebral bock with LB reduces opioid use (a ∼ 23 % reduction) and the incidence of rebound pain in children after the Nuss procedure compared to nLB group.

TRIAL REGISTRATION

www.chictr.org.cn (Registration number ChiCTR2400085350, Registration date June 5, 2024).

摘要

研究目的

漏斗胸微创修复术(努斯手术)与术后显著疼痛和高剂量阿片类药物使用相关。脂质体布比卡因(LB)作为一种超长效局部麻醉剂,已被广泛研究用于围手术期镇痛。然而,关于LB对接受努斯手术儿童术后疼痛影响的数据仍然有限。本研究的目的是评估LB减少接受努斯手术儿童术后阿片类药物使用的能力。

设计

随机对照试验。

地点

手术室。

患者

计划接受择期努斯手术的6至18岁儿童。

干预措施

麻醉诱导后,患者被随机分配接受超声引导下椎旁阻滞,使用LB或非脂质体布比卡因(nLB)。

测量指标

主要结局是术后72小时内吗啡当量的消耗量。次要终点包括72小时内最大数字评分量表(NRS)疼痛评分、72小时内中重度疼痛发生率、72小时内反弹痛发生率、术后3天NRS睡眠评分、术后恶心呕吐发生率、术后住院时间以及术后首次下床活动时间。

主要结果

意向性分析共纳入109名受试者。术后72小时内,LB组的吗啡当量消耗量比nLB组减少了约23%(中位数差异:23.1毫克;P = 0.023)。LB组的反弹痛发生率显著低于nLB组(13.0% [7/54] 对29.1% [16/55],相对风险0.46;95% CI:0.20至0.96;P = 0.039)。术后第二晚和第三晚,LB组的主观睡眠质量优于nLB组(中位数差异:-1分;P = 0.005和P = 0.016)。两组不良事件发生率相似,研究期间无患者发生严重不良事件。

结论

与nLB组相比,LB椎旁阻滞可减少接受努斯手术儿童的阿片类药物使用(减少约23%)和反弹痛发生率。

试验注册

www.chictr.org.cn(注册号ChiCTR2400085350,注册日期2024年6月5日)。

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