【原】【经典高分文献阅读】胸神经阻滞用于隆胸手术——一项随机、双盲、双中心对照试验

经典高分文献阅读·胸神经阻滞用于隆胸手术——一项随机、双盲、双中心对照试验

署名：Riozhou/FXX

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01

Editor’s Perspective

What We Already Know about This Topic

· Moderate levels of pain may be experienced after breast augmentation surgery

· It is unclear whether pectoral nerve blocks add clinically significant benefit to a multimodal analgesic regime after breast augmentation

What This Article Tells Us That Is New

· Patients undergoing breast augmentation who received pectoral nerve blocks in addition to multimodal analgesia experienced less pain in the first 6 h postoperatively and lower maximal pain scores between postoperative days 1 through 5

· The use of pectoral nerve blocks also reduced opioid consumption up to 5 d after surgery

既往已知：

· 隆胸手术后可能会经历中等程度的疼痛

· 胸神经阻滞是否对隆胸手术后的多模式镇痛方案有明显的临床好处尚不明确

本文新发现：

· 在多模式镇痛的基础上加用胸神经阻滞后接受隆胸手术的患者，术后前6小时疼痛较轻，术后第1至5天最大疼痛评分较低

· 胸神经阻滞的运用也减少了术后5天的阿片类药物的使用

02

Background:

· 隆乳手术是最流行的整形外科手术之一。

· 由于外科解剖、肌肉损伤和乳房组织扩张，植入乳房假体会引起术后的主要疼痛。

· 最近，胸神经阻滞被提出用于乳房手术期间和之后的镇痛。最近研究表明胸神经阻滞效果不低于椎旁阻滞。在隆乳手术后使用胸神经阻滞镇痛的证据仍然很少。

· 我们认为：在系统性多模式镇痛方案中加用术前神经阻滞，能提供更好的镇痛效果，并减少阿片类药物的消耗。

03

Methods:

（一）纳入排除标准

· A multicenter, prospective, randomized, double-blind, controlled, superiority clinical trial.

· Female adult patients,  scheduled for prosthetic breast augmentation under general anesthesia,  were eligible for participation in the study if they were affiliated with the national health insurance system and had an American Society of Anesthesiologists physical status I to III.

· Patients were not eligible if they were pregnant or breastfeeding,  had cognitive impairment with difficulties in pain evaluation (vulnerable people),  were protected minor or major patients with consent incapacity , had an allergy to local anesthetics or any contraindication to use the analgesics of our protocol, had severe coagulopathy , were on treatment for chronic pain, were participating in another research, or were scheduled for revision surgery or prosthesis change (table 1).

· 一项多中心、前瞻性、随机、双盲、对照的临床试验。

· 纳入标准：计划在全麻下行假体隆胸的成年女性，隶属于国家医疗保险系统；ASA分级I级-III级。

· 排除标准：怀孕或哺乳，有疼痛评估困难的认知障碍，受保护的无同意能力的患者，对局麻药过敏或有任何使用本方案镇痛药的禁忌症，有严重的凝血障碍，正在接受慢性疼痛的治疗，参加另一项研究，或计划进行再次修复或更换假体手术。

（二）方案实施

· General Anesthesia:  Standardized intraoperative protocol was performed in both groups.

· General anesthesia was induced with target-controlled infusion of remifentanil and propofol.

· Remifentanil target was lowered to 1ng/ml, and anesthesia was maintained with sevoflurane in air/oxygen.  

· Maintain heart rate and arterial blood pressure within 20% of the baseline values.

· Nitrousoxide, clonidine, dexmedetomidine, and ketamine administration were not allowed.

· 两组均采用标准化的术中方案。靶控输注瑞芬太尼和异丙酚诱导全身麻醉。瑞芬太尼、七氟醚维持麻醉。

· 术中将心率和动脉压维持在基线值的20%以内。

· 不允许使用一氧化氮、可乐定、右美托咪啶和氯胺酮。

· Postoperative Care: Thirty minutes before the end of surgery , 1,000 mg acetaminophen, 100 mg ketoprofen, and 20 mg nefopam were infused.

· Analgesia was assessed at rest, every 30 min for 2 h in the PACU, and then every 2 h until hour 6 in the ambulatory or surgical ward.29 If numerical rating scale was between 4 and 6, IV tramadol (50 to 100 mg) was administered according to patient’s body weight (50 mg if the patient weighed less than 60 kg), and IV morphine titration, 2 to 3 mg every 5 min if the numerical rating scale was greater than 6.

· Postoperative nausea and vomiting were treated with IV ondansetron (4 mg).

· 手术结束前30分钟，输注扑热息痛1000 mg、酮洛芬100 mg、奈福泮20 mg。

· 疼痛程度是在静息状态下评估的，在PACU中每30分钟评估一次，持续2小时，然后在日间或外科病房中每2小时评估一次，持续第6小时。如果NRS在4到6之间，则根据患者的体重(如果患者体重小于60公斤，则为50毫克)给予静脉曲马多(50到100毫克)，如果数值评分大于6，则为静脉吗啡滴定，每5分钟2到3毫克。

· 术后恶心和呕吐用静脉注射昂丹司琼(4毫克)治疗。

（三）神经阻滞

· PECS Block: In the PECS group, the blocks were performed with patient in the supine position with the arm abducted.

· For control group, the PECS was not performed but the ultrasound location of the region of interest was carried out to maintain the blinding of the procedure for the treating team.

· At the end of the “PECS/control procedure, ” in both groups, a sterile dressing was applied on the puncture zone.

· Then the treating team was allowed to come back and take over anesthesia management.

· PECS组患者采用仰卧位，手臂外展进行阻滞。

· 对照组不进行PECS，但对感兴趣区进行超声定位，以保持治疗组手术的盲目性。

· 在阻滞结束时，两组均在穿刺区涂抹无菌敷料。

· 治疗团队允许回来接管麻醉管理。

（四）结局指标

· Outcome Variables: The primary outcome measure was the maximal numerical rating scale measured in the first 6 h after extubation. A priori secondary outcomes were the maximal numerical rating scale from hour 6 to day 1 (surgeon’s consultation) and from day 1 to day 5 (phone interview), the intraoperative remifentanil consumption; the postoperative global opioid consumption in oral morphine equivalent, and the incidence of opioid side effects such as postoperative nausea and vomiting, constipation, and pruritus during the first 6 h, from hour 6 to day 1 (surgeon’s consultation), and from day 1 to day 5 (phone interview), and global satisfaction at day 5. Any adverse effects, such as hypotension and respiratory depression, were recorded.

· 主要的结果测量：拔管后第一个6小时测量的最大NRS评分。

· 优先的次要结果：从第6小时到第1天(外科医生会诊)和从第1天到第5天(电话随访)的最大NRS评分，术中瑞芬太尼消耗量；口服吗啡当量的术后总体阿片类药物消耗量，以及术后前6h、第6小时至第1天(外科医生会诊)和第1天至第5天(电话随访)期间阿片类药物副作用(如术后恶心呕吐、便秘和瘙痒)的发生率，以及第5天的总体满意度。记录任何不良反应，如低血压和呼吸抑制。

04

Results:

（一）流程

· Finally, 73 patients were included in the final intent-to-treat analysis. We observed four protocol deviations: one patient who was enrolled despite a surgery for prosthesis change, and three patients who received an unplanned subcutaneous infiltration of local anesthetic by the surgeon at the end of surgery. Thus, intent-to-treat analysis was performed on 73 patents, and per-protocol analysis was performed on 69 patients.

· 最后，73名患者被纳入最终意向治疗分析。我们观察到四个方案偏差：一名患者尽管接受了假体置换手术，但仍被纳入分析，并且有三名患者在手术结束时接受了外科医生计划外的局部麻醉剂皮下渗透。因此，对73例患者进行了意向治疗分析，对69例患者进行方案分析。

（二）组间比较

· 术后第一个6小时的疼痛评分在PECS组中统计学上较低。

· 两组之间的最大差异出现在拔管后的第一个小时内。

· 在PECS组和对照组中，首次追加镇痛药前的时间和这6小时阿片类药物总消耗量(口服吗啡当量) 均没有差异。

· 在“第6小时至第1天”期间(拔管后6小时至外科会诊)，最大NRS评分无统计学意义，但PECS组的阿片类药物消耗量较低。

· 在“第1天至第5天”期间(从外科医生咨询到电话采访)，PECS组的最大NRS评分和阿片类药物消耗量较低。

· 关于阿片类药物相关的副作用，两组之间在所有时间点的术后恶心呕吐、瘙痒或便秘没有统计学上的显著差异。

· 两组患者的满意度都非常好。在PECS组中，满意度良好的患者比例(超过10分之7的数值)在统计学上更高。

（三）总结

· Finally, a per-protocol analysis was performed including 69 patients among 73. Similar results were found for the primary outcome (maximal numerical rating scale in the first 6 h after extubation). Similar results were also found for the mean numerical rating scale recorded every 30 min for 2 h and then every 2 h until hour. The maximal numerical rating scales from hour 6 to day 1 and from day 1 to day 5 were lower in the PECS group, but the difference was not significant. Maximal remifentanil site effect and opioid consumption in oral morphine equivalent from hour 6 to day 1 and from day 1 to day 5 were all statistically significantly lower in the PECS group, whereas opioid consumption in the first 6 h was not as for the intention-to-treat analysis.

· 最后，对73名患者中的69名进行了方案分析。对于主要结果(拔管后最初6小时的最大NRS评分)和记录的平均NRS评分也发现了类似的结果。PECS组第6小时至第1天和第1天至第5天的最大NRS评分较低，但差异不显著。在PECS组中，瑞芬太尼副作用和阿片样物质消耗量所换算的口服吗啡当量均较低，而在意向治疗分析中，两组间前6小时的阿片类药物消耗量的统计学差异并不显著。

05

Discussion:

美容隆胸手术的镇痛受到的关注较少。然而，隆胸手术产生的疼痛与改良根治性乳房切除术后的疼痛非常相似。事实上，植入所需的解剖涉及胸大肌及其与肋骨的附着的破坏。在某些情况下，肌肉纤维被分开以进入胸肌之间的平面，胸大肌的伸展很大。肌肉下隆胸疼痛的主要来源是肌筋膜，由胸神经传递。皮肤切口可以是乳晕周围、乳房下或腋下。与皮肤切口有关的疼痛所涉及的神经分别是从T2到T4或从T5到T6的肋间神经的前支和侧支，或长胸神经，有时也有一些来自锁骨上神经的分支，这取决于植入物的大小。

PECS是一种相对较新的筋膜平面阻滞，目的是为了在上前胸壁发挥镇痛作用。PEC I以胸廓内侧和外侧神经为靶点，对胸肌进行镇痛。PEC II针对肋间神经和长胸神经的几个部分。这些神经阻断后以便在乳房手术中提供有效的镇痛。

与其他描述的乳房手术技术(如椎旁阻滞)相比，PECS的并发症更少。这些阻滞已用于乳腺癌手术期间和之后的镇痛，并具有相关的镇痛效果。仍然缺乏高质量的证据支持这些方法在美容乳房手术中的镇痛效果。小规模随机对照试验评估了用于隆胸手术的PECS，结果各不相同。

胸椎旁阻滞建议用于大型乳房手术，但不适用于隆胸手术。事实上，不完全麻醉可能是不够的，因为来自浅颈丛、胸神经、长胸神经和胸背神经的锁骨上分支没有被胸椎旁阻滞所阻滞。另一方面，胸椎旁阻滞涉及气胸、脊髓损伤、交感神经阻滞和低血压的风险。更罕见的是，胸椎旁阻滞可能变成硬膜外阻滞或可能导致全脊髓麻醉。因此，考虑到可能的副作用，它可能不适合日间手术。最近，Hussain等人进行了这项系统综述和荟萃分析，确定了PECS的潜在临床作用。他们发现，在乳腺癌手术后的24小时内，两组患者的疼痛评分或阿片类药物消耗量没有差异，并且两者都优于单独的全身镇痛。

竖脊肌平面阻滞已被提议作为计划进行大型乳房手术的患者的PECS阻滞的替代方案。在最近的两项研究中，作者未能证明竖脊肌平面阻滞的优越性，在PECS组中，阿片类药物的消耗和疼痛评分在统计学上显著降低。

这项研究有几个局限性。主要的限制是对照组没有使用安慰剂。PECS作为筋膜间平面阻滞，需要大量的局麻药。我们认为注射10和15ml的生理盐水本身可能会产生疼痛。

· 此外，在研究(PECS程序)和一般管理(患者管理和数据记录)中，使用不同的麻醉团队执行了非常严格的盲法程序。没有进行皮肤冷感测试，意味着没有确认正确的阻滞范围。然而，冷刺激可能与用于术后疼痛的区域镇痛的扩散范围和效率相关性较差。

· 术后痛觉过敏也未得到评估。区域麻醉可有效预防痛觉过敏。这可能解释了最后4天随访期间阿片类药物消耗的差异。

· 所有手术程序都不一样。事实上，假体可能位于胸膜前或胸膜下，这可能导致不同的术后疼痛。

· 136名患者接受了资格筛选，只有74名患者被随机分组。一些患者拒绝随机化，希望一定程度上实现PECS阻滞，同时，研究中的主要的整形外科医生意外的退出了。

06

Conclusions

· Pre-incisional PECS block associated with recommended multimodal analgesia is an effective and safe technique that provides better postoperative analgesia immediately and over 5 days of follow-up; moreover, it is associated with lower opioid consumption. Further studies are required to assess the clinical effect of PECS for preventing chronic postsurgical pain after breast augmentation.

· 术前PECS阻滞联合推荐的多模式镇痛是一种有效和安全的技术，可立即提供更好的术后镇痛效果，并可进行超过5天的随访；此外，它与较低的阿片类药物消耗量有关。需要进一步的研究来评估PECS预防隆乳术后慢性疼痛的临床效果。