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椎旁与胸肌 II (胸内和胸肌)神经阻滞用于非乳房切除术乳房手术后的术后镇痛:一项随机、对照、观察者设盲非劣效性试验。

Paravertebral versus Pectoralis-II (Interpectoral and Pectoserratus) Nerve Blocks for Postoperative Analgesia after Nonmastectomy Breast Surgery: A Randomized, Controlled, Observer-masked Noninferiority Trial.

机构信息

Division of Regional Anesthesia, Department of Anesthesiology, University of California, San Diego, La Jolla, California; Division of Biomedical Informatics, Department of Medicine, University of California, San Diego, La Jolla, California; and Outcomes Research Consortium, Cleveland, Ohio.

Division of Regional Anesthesia, Department of Anesthesiology, University of California, San Diego, La Jolla, California.

出版信息

Anesthesiology. 2024 Dec 1;141(6):1039-1050. doi: 10.1097/ALN.0000000000005207.

DOI:10.1097/ALN.0000000000005207
PMID:39186671
Abstract

BACKGROUND

Pectoralis-II and paravertebral nerve blocks are both used to treat pain after breast surgery. Most previous studies involving mastectomy identified little difference of significance between the two approaches. Whether this is also accurate for nonmastectomy procedures remains unknown.

METHODS

Participants undergoing uni- or bilateral nonmastectomy breast surgery anticipated to have at least moderate postoperative pain were randomized to a pectoralis-II or paravertebral block (90 mg ropivacaine per side for both). Surgeons and recovery room staff were masked to treatment group assignment, and participants were not informed of their treatment group. Injectate for pectoralis-II blocks was ropivacaine 0.3% (30 ml) per side. Injectate for paravertebral blocks was ropivacaine 0.5% (9 ml in each of two levels) per side. This study hypothesized that pectoralis-II blocks would have noninferior analgesia (numeric rating scale) and noninferior cumulative opioid consumption within the operating and recovery rooms combined (dual primary outcomes). The study was adequately powered with n = 100, but the target enrollment was raised to n = 150 to account for higher-than-anticipated variability.

RESULTS

The trial was ended prematurely with 119 (79%) of the original target of 150 participants enrolled due to (masked) surgeon preference. Within the recovery room, pain scores were higher in participants with pectoralis-II (n = 60) than paravertebral blocks (n = 59): median [interquartile range], 3.3 [2.3, 4.8] versus 1.3 [0, 3.6] (95% CI, 0.5 to 2.6; P < 0.001). Similarly, intravenous morphine equivalents were higher in the pectoralis-II group: 17.5 [12.5, 21.9] versus 10.0 mg [10, 20] (95% CI, 0.1 to 7.5; P = 0.004). No block-related adverse events were identified in either group.

CONCLUSIONS

After nonmastectomy breast surgery, two-level paravertebral blocks provided superior analgesia and opioid sparing compared with pectoralis-II blocks. This is a contrary finding to the majority of studies in patients having mastectomy, in which little significant difference was identified between the two types of blocks.

摘要

背景

胸大肌肌间沟阻滞和椎旁神经阻滞均可用于治疗乳房手术后的疼痛。大多数涉及乳房切除术的既往研究表明,这两种方法之间的差异无统计学意义。对于非乳房切除术手术,这种情况是否仍然准确尚不清楚。

方法

接受单侧或双侧非乳房切除术的乳房手术患者预计术后会有中度以上疼痛,他们被随机分配到胸大肌肌间沟阻滞或椎旁阻滞组(每侧罗哌卡因 90mg)。外科医生和恢复室工作人员对治疗组的分配进行了掩蔽,而患者则不知道他们的治疗组。胸大肌肌间沟阻滞的注射剂为罗哌卡因 0.3%(每侧 30ml)。椎旁阻滞的注射剂为罗哌卡因 0.5%(每侧两个水平各 9ml)。本研究假设胸大肌肌间沟阻滞在手术和恢复室联合使用时具有非劣效的镇痛作用(数字评分量表)和非劣效的累积阿片类药物消耗(双重主要结局)。该研究有足够的效力,n = 100,但目标入组人数增加到 n = 150,以考虑到高于预期的变异性。

结果

由于(掩蔽的)外科医生的偏好,该试验提前结束,最初目标的 150 名参与者中的 119 名(79%)入组。在恢复室中,接受胸大肌肌间沟阻滞(n = 60)的患者疼痛评分高于接受椎旁阻滞(n = 59)的患者:中位数[四分位距],3.3[2.3,4.8]与 1.3[0,3.6](95%CI,0.5 至 2.6;P < 0.001)。同样,胸大肌肌间沟阻滞组静脉注射吗啡等效物更高:17.5[12.5,21.9]与 10.0mg[10,20](95%CI,0.1 至 7.5;P = 0.004)。两组均未发现与阻滞相关的不良事件。

结论

在非乳房切除术乳房手术后,与胸大肌肌间沟阻滞相比,两水平椎旁阻滞提供了更好的镇痛效果和阿片类药物节省作用。这与大多数在接受乳房切除术的患者中进行的研究结果相反,在这些研究中,两种类型的阻滞之间几乎没有发现显著差异。

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