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低容量与高容量罗哌卡因用于双颌手术超声引导下上颌神经阻滞的有效性:一项随机非劣效性试验

Effectiveness of Low-Volume Versus High-Volume Ropivacaine for Ultrasound-Guided Maxillary Nerve Block in Double-Jaw Surgery: A Randomized Non-inferiority Trial.

作者信息

Chen Ming-Kai, Zhao Le, Luo Wei, Luo Kai, Lin Jie, Ji Yang

机构信息

State Key Laboratory of Oral Diseases & National Center for Stomatology & National Clinical Research Center for Oral Diseases & Department of Anesthesiology, West China Hospital of Stomatology, Sichuan University, Chengdu, China.

出版信息

Aesthetic Plast Surg. 2025 Mar;49(5):1217-1226. doi: 10.1007/s00266-025-04671-9. Epub 2025 Jan 16.

DOI:10.1007/s00266-025-04671-9
PMID:39821295
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11965159/
Abstract

BACKGROUND

Ultrasound-guided maxillary nerve block (UGMNB) is applied in oral and maxillofacial surgery to improve perioperative analgesia, decrease the risk of postoperative nausea and vomiting, and enhance recovery. However, the optimum volume of ropivacaine used for UGMNB is undetermined. Thus, it was hypothesized that in patients undergoing double-jaw surgery, low- and high-volume ropivacaine reduces perioperative pain with similar efficacy.

METHODS

Adults undergoing double-jaw surgery were enrolled in a randomized non-inferiority trial to receive a bilateral single-injection UGMNB with 2 mL (low-volume [LV] group) or 5 mL (high-volume [HV] group) of 0.375% ropivacaine on each side. A visual analog scale (VAS) score for maxillary pain at 2 h postoperatively was taken as the primary outcome. VAS score for maxillary and mandibular pain at 2, 4, 6, 8, 12, 24, and 48 h postoperatively, hemodynamic changes intraoperatively, consumption of intraoperative opioids and sedatives, vasoactive medication use, extubation time, postoperative rescue analgesia, time to the first analgesia, postoperative nausea and vomiting and UGMNB-related complications within 48 h post-surgery were assessed as the secondary outcomes.

RESULTS

Sixty-four adults were included. The maxillary pain score in the LV group was not inferior to that in the HV group at 2 h postoperatively, with a non-inferiority margin of 1 (mean difference - 0.1; 95% confidence interval [CI] - 0.6 to 0.8, P = 0.414 for non-inferiority). Maxillary and mandibular pain demonstrated no difference in the measured times between groups. The incidence of postoperative nausea was significantly higher in the LV group than that in the HV group at 6-24 h (12 (37.5%) vs. 5 (15.6%), P = 0.048). Moreover, no differences in intraoperative hemodynamic parameters, medications during anesthesia, time to extubation, rescue analgesia, time to the first analgesia, and postoperative vomiting were observed. Only one patient in the LV group was observed to have maxillary nerve block-related complications.

CONCLUSIONS

To conclude, the efficacy of UGMNB with 2 mL of 0.375% ropivacaine has the same efficacy as the 5 mL drug in reducing perioperative pain in patients undergoing double-jaw surgery.

LEVEL OF EVIDENCE I

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

摘要

背景

超声引导下上颌神经阻滞(UGMNB)应用于口腔颌面外科手术,以改善围手术期镇痛,降低术后恶心呕吐风险,并促进恢复。然而,用于UGMNB的罗哌卡因最佳剂量尚未确定。因此,有假设认为,在接受双颌手术的患者中,低剂量和高剂量罗哌卡因减轻围手术期疼痛的效果相似。

方法

将接受双颌手术的成年人纳入一项随机非劣效性试验,每侧接受2 mL(低剂量组[LV])或5 mL(高剂量组[HV])0.375%罗哌卡因的双侧单次注射UGMNB。将术后2小时上颌疼痛的视觉模拟量表(VAS)评分作为主要结局。将术后2、4、6、8、12、24和48小时上颌和下颌疼痛的VAS评分、术中血流动力学变化、术中阿片类药物和镇静剂的消耗量、血管活性药物的使用、拔管时间、术后补救镇痛、首次镇痛时间、术后恶心呕吐以及术后48小时内与UGMNB相关的并发症作为次要结局进行评估。

结果

纳入64名成年人。术后2小时,LV组的上颌疼痛评分不劣于HV组,非劣效界值为1(平均差值 -0.1;95%置信区间[CI] -0.6至0.8,非劣效性检验P = 0.414)。上颌和下颌疼痛在各测量时间点两组间无差异。LV组术后6 - 24小时恶心发生率显著高于HV组(12例(37.5%)对5例(15.6%),P = 0.048)。此外,术中血流动力学参数、麻醉期间用药、拔管时间、补救镇痛、首次镇痛时间和术后呕吐方面未观察到差异。LV组仅1例患者出现与上颌神经阻滞相关的并发症。

结论

总之,在接受双颌手术的患者中,2 mL 0.375%罗哌卡因的UGMNB在减轻围手术期疼痛方面与5 mL药物具有相同疗效。

证据水平I:本期刊要求作者为每篇文章指定证据水平。有关这些循证医学评级的完整描述,请参阅目录或在线作者指南www.springer.com/00266 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7bd/11965159/5494f0f37cce/266_2025_4671_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7bd/11965159/e8ea8ca32c79/266_2025_4671_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7bd/11965159/5494f0f37cce/266_2025_4671_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7bd/11965159/e8ea8ca32c79/266_2025_4671_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7bd/11965159/f571095a0090/266_2025_4671_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7bd/11965159/2cd766a63329/266_2025_4671_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7bd/11965159/5494f0f37cce/266_2025_4671_Fig4_HTML.jpg

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本文引用的文献

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J Oral Maxillofac Surg. 2024 Apr;82(4):412-421. doi: 10.1016/j.joms.2023.12.018. Epub 2024 Jan 2.
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Is Postoperative Pain Associated With Nausea and Vomiting Following Orthognathic Surgery?正颌手术后的疼痛与恶心和呕吐有关吗?
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Perioperative Nerve Blockade Reduces Acute Postoperative Pain after Orthognathic Surgery.
围手术期神经阻滞可减少正颌手术后的急性术后疼痛。
Pain Res Manag. 2023 Dec 19;2023:7306133. doi: 10.1155/2023/7306133. eCollection 2023.
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Effectiveness of different protocols to reduce postoperative pain following orthognathic surgery: A systematic review and meta-analysis.不同方案减少正颌术后疼痛的效果:系统评价和荟萃分析。
Br J Oral Maxillofac Surg. 2022 Sep;60(7):e1-e10. doi: 10.1016/j.bjoms.2022.03.013. Epub 2022 Apr 23.
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Efficacy of gastric aspiration to reduce postoperative vomiting after orthognathic surgery: double-blind randomised clinical trial.经口胃吸引术减少正颌手术后呕吐的效果:双盲随机临床试验。
Br J Oral Maxillofac Surg. 2022 May;60(4):493-498. doi: 10.1016/j.bjoms.2021.09.003. Epub 2021 Sep 16.
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Ultrasound-Guided Suprazygomatic Nerve Blocks to the Pterygopalatine Fossa: A Safe Procedure.超声引导颧弓下入翼腭窝神经阻滞:一种安全的方法。
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