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肩胛上神经阻滞中脂质体布比卡因与普通布比卡因比较:一项双盲前瞻性随机对照试验。

Liposomal bupivacaine interscalene nerve block in shoulder arthroplasty is not superior to plain bupivacaine: a double-blinded prospective randomized control trial.

机构信息

Department of Orthopedic Surgery, Mayo Clinic Arizona, Phoenix, AZ, USA.

Department of Orthopedic Surgery, Mayo Clinic Arizona, Phoenix, AZ, USA.

出版信息

J Shoulder Elbow Surg. 2021 Mar;30(3):587-598. doi: 10.1016/j.jse.2020.09.017. Epub 2020 Oct 9.

DOI:10.1016/j.jse.2020.09.017
PMID:33045330
Abstract

BACKGROUND

Interscalene brachial plexus blocks are a common modality used to provide adjunctive pain relief with shoulder replacement surgery. In 2018, the Federal Drug Administration approved the use of liposomal bupivacaine (LB) for such nerve blocks. We sought to evaluate whether this formulation of bupivacaine would provide superior pain relief for shoulder replacement patients over standard bupivacaine alone. Our hypotheses were that in the LB cohort the average postoperative pain score over the first 72 hours would be significantly lower, time to block cessation would be longer, total opioid consumption would be lower, and the average patient satisfaction score regarding their pain management would be higher.

MATERIALS AND METHODS

A randomized, double-blinded study was designed comparing primary shoulder replacement surgery after an interscalene block with 25 mL of 0.5% plain bupivacaine vs. 133 mg of LB with 7.5 mL of 0.5% and 7.5 mL of 0.25% plain bupivacaine. A total of 104 patients were included in the study, with an equal number in each study arm. Patients' visual analog pain scores (VAPS) were followed for their inpatient stay, first 3 full outpatient days, and at a 3-week follow-up. Use of opioid medication was recorded for the same intervals and converted to morphine milligram equivalents. The time to first opioid rescue was documented, as well as the patients' satisfaction with their pain management at both the 3-day and 3-week intervals.

RESULTS

No clinically relevant advantage to the use of LB over plain bupivacaine was found. During the second postoperative day, the mean VAPS was 2.4 with LB vs. 3.3 in the standard cohort (P = .0409). The only other statistically significant finding was a higher VAPS with LB during the third full day home compared with standard bupivacaine (4.0 vs. 2.8, respectively, P = .0197). Both of these differences were less than the minimal clinically important difference of 2 for the VAPS. Analysis of the VAPS for the first and third postoperative days, the first and second full days home, and at 3 weeks revealed no significant difference. Similarly, there was no significant difference in time to first opioid rescue, total morphine milligram equivalent use, and patient satisfaction with pain management.

CONCLUSION

When used for an interscalene block to provide adjunctive pain relief in shoulder replacement surgery, the addition of LB to plain bupivacaine provides no additional clinically important benefit to the patient's pain experience over standard bupivacaine.

摘要

背景

经锁骨上臂丛神经阻滞是一种常用于肩关节置换术辅助止痛的常见方法。2018 年,美国食品和药物管理局批准了脂质体布比卡因(LB)在这种神经阻滞中的应用。我们试图评估这种布比卡因制剂是否能为肩关节置换患者提供比单纯布比卡因更好的止痛效果。我们的假设是,在 LB 组中,术后 72 小时内的平均术后疼痛评分将显著降低,阻滞停止时间将延长,总阿片类药物消耗量将降低,以及患者对疼痛管理的平均满意度评分将更高。

材料和方法

设计了一项随机、双盲研究,比较了在经锁骨上臂丛神经阻滞中使用 25 毫升 0.5%布比卡因的单纯布比卡因与使用 133 毫克 LB 加 7.5 毫升 0.5%和 7.5 毫升 0.25%布比卡因的患者的原发性肩关节置换手术后的情况。共有 104 名患者纳入研究,每组各有 52 名患者。在住院期间、术后前 3 个完整的门诊日以及术后 3 周随访期间,记录患者的视觉模拟疼痛评分(VAPS)。记录相同时间内阿片类药物的使用情况,并转换为吗啡毫克当量。记录首次使用阿片类药物解救的时间,以及患者在 3 天和 3 周时对疼痛管理的满意度。

结果

与单纯布比卡因相比,使用 LB 并没有发现具有临床意义的优势。术后第 2 天,LB 组的平均 VAPS 为 2.4,标准组为 3.3(P =.0409)。唯一另一个具有统计学意义的发现是,LB 组在第 3 天在家时的 VAPS 高于标准布比卡因组(分别为 4.0 与 2.8,P =.0197)。这两个差异均小于 VAPS 的 2 分最小临床重要差异。对术后第 1 天和第 3 天、第 1 天和第 2 天在家以及术后 3 周的 VAPS 进行分析,没有发现显著差异。同样,首次使用阿片类药物解救的时间、总吗啡毫克当量使用量和患者对疼痛管理的满意度也没有显著差异。

结论

在肩关节置换术中,经锁骨上臂丛神经阻滞中使用 LB 联合单纯布比卡因,与单纯使用布比卡因相比,患者的疼痛体验没有明显的临床获益。

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