經(jīng)典高分文獻閱讀·胸神經(jīng)阻滯用于隆胸手術(shù)——一項隨機、雙盲、雙中心對照試驗
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01
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：
· 隆胸手術(shù)后可能會經(jīng)歷中等程度的疼痛
· 胸神經(jīng)阻滯是否對隆胸手術(shù)后的多模式鎮(zhèn)痛方案有明顯的臨床好處尚不明確
本文新發(fā)現(xiàn)：
· 在多模式鎮(zhèn)痛的基礎(chǔ)上加用胸神經(jīng)阻滯后接受隆胸手術(shù)的患者，術(shù)后前6小時疼痛較輕，術(shù)后第1至5天最大疼痛評分較低
· 胸神經(jīng)阻滯的運用也減少了術(shù)后5天的阿片類藥物的使用
02
· 隆乳手術(shù)是最流行的整形外科手術(shù)之一。
· 由于外科解剖、肌肉損傷和乳房組織擴張，植入乳房假體會引起術(shù)后的主要疼痛。
· 最近，胸神經(jīng)阻滯被提出用于乳房手術(shù)期間和之后的鎮(zhèn)痛。最近研究表明胸神經(jīng)阻滯效果不低于椎旁阻滯。在隆乳手術(shù)后使用胸神經(jīng)阻滯鎮(zhèn)痛的證據(jù)仍然很少。
· 我們認為：在系統(tǒng)性多模式鎮(zhèn)痛方案中加用術(shù)前神經(jīng)阻滯，能提供更好的鎮(zhèn)痛效果，并減少阿片類藥物的消耗。
03
（一）納入排除標(biāo)準
· 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).
· 一項多中心、前瞻性、隨機、雙盲、對照的臨床試驗。
· 納入標(biāo)準：計劃在全麻下行假體隆胸的成年女性，隸屬于國家醫(yī)療保險系統(tǒng)；ASA分級I級-III級。
· 排除標(biāo)準：懷孕或哺乳，有疼痛評估困難的認知障礙，受保護的無同意能力的患者，對局麻藥過敏或有任何使用本方案鎮(zhèn)痛藥的禁忌癥，有嚴重的凝血障礙，正在接受慢性疼痛的治療，參加另一項研究，或計劃進行再次修復(fù)或更換假體手術(shù)。
（二）方案實施
· 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.
· 兩組均采用標(biāo)準化的術(shù)中方案。靶控輸注瑞芬太尼和異丙酚誘導(dǎo)全身麻醉。瑞芬太尼、七氟醚維持麻醉。
· 術(shù)中將心率和動脈壓維持在基線值的20%以內(nèi)。
· 不允許使用一氧化氮、可樂定、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).
· 手術(shù)結(jié)束前30分鐘，輸注撲熱息痛1000 mg、酮洛芬100 mg、奈福泮20 mg。
· 疼痛程度是在靜息狀態(tài)下評估的，在PACU中每30分鐘評估一次，持續(xù)2小時，然后在日間或外科病房中每2小時評估一次，持續(xù)第6小時。如果NRS在4到6之間，則根據(jù)患者的體重(如果患者體重小于60公斤，則為50毫克)給予靜脈曲馬多(50到100毫克)，如果數(shù)值評分大于6，則為靜脈嗎啡滴定，每5分鐘2到3毫克。
· 術(shù)后惡心和嘔吐用靜脈注射昂丹司瓊(4毫克)治療。
（三）神經(jīng)阻滯
· 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組患者采用仰臥位，手臂外展進行阻滯。
· 對照組不進行PECS，但對感興趣區(qū)進行超聲定位，以保持治療組手術(shù)的盲目性。
· 在阻滯結(jié)束時，兩組均在穿刺區(qū)涂抹無菌敷料。
· 治療團隊允許回來接管麻醉管理。
（四）結(jié)局指標(biāo)
· 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.
· 主要的結(jié)果測量：拔管后第一個6小時測量的最大NRS評分。
· 優(yōu)先的次要結(jié)果：從第6小時到第1天(外科醫(yī)生會診)和從第1天到第5天(電話隨訪)的最大NRS評分，術(shù)中瑞芬太尼消耗量；口服嗎啡當(dāng)量的術(shù)后總體阿片類藥物消耗量，以及術(shù)后前6h、第6小時至第1天(外科醫(yī)生會診)和第1天至第5天(電話隨訪)期間阿片類藥物副作用(如術(shù)后惡心嘔吐、便秘和瘙癢)的發(fā)生率，以及第5天的總體滿意度。記錄任何不良反應(yīng)，如低血壓和呼吸抑制。
04
（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名患者被納入最終意向治療分析。我們觀察到四個方案偏差：一名患者盡管接受了假體置換手術(shù)，但仍被納入分析，并且有三名患者在手術(shù)結(jié)束時接受了外科醫(yī)生計劃外的局部麻醉劑皮下滲透。因此，對73例患者進行了意向治療分析，對69例患者進行方案分析。
（二）組間比較
· 術(shù)后第一個6小時的疼痛評分在PECS組中統(tǒng)計學(xué)上較低。
· 兩組之間的最大差異出現(xiàn)在拔管后的第一個小時內(nèi)。
· 在PECS組和對照組中，首次追加鎮(zhèn)痛藥前的時間和這6小時阿片類藥物總消耗量(口服嗎啡當(dāng)量) 均沒有差異。
· 在“第6小時至第1天”期間(拔管后6小時至外科會診)，最大NRS評分無統(tǒng)計學(xué)意義，但PECS組的阿片類藥物消耗量較低。
· 在“第1天至第5天”期間(從外科醫(yī)生咨詢到電話采訪)，PECS組的最大NRS評分和阿片類藥物消耗量較低。
· 關(guān)于阿片類藥物相關(guān)的副作用，兩組之間在所有時間點的術(shù)后惡心嘔吐、瘙癢或便秘沒有統(tǒng)計學(xué)上的顯著差異。
· 兩組患者的滿意度都非常好。在PECS組中，滿意度良好的患者比例(超過10分之7的數(shù)值)在統(tǒng)計學(xué)上更高。
（三）總結(jié)
· 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，對73名患者中的69名進行了方案分析。對于主要結(jié)果(拔管后最初6小時的最大NRS評分)和記錄的平均NRS評分也發(fā)現(xiàn)了類似的結(jié)果。PECS組第6小時至第1天和第1天至第5天的最大NRS評分較低，但差異不顯著。在PECS組中，瑞芬太尼副作用和阿片樣物質(zhì)消耗量所換算的口服嗎啡當(dāng)量均較低，而在意向治療分析中，兩組間前6小時的阿片類藥物消耗量的統(tǒng)計學(xué)差異并不顯著。
05
美容隆胸手術(shù)的鎮(zhèn)痛受到的關(guān)注較少。然而，隆胸手術(shù)產(chǎn)生的疼痛與改良根治性乳房切除術(shù)后的疼痛非常相似。事實上，植入所需的解剖涉及胸大肌及其與肋骨的附著的破壞。在某些情況下，肌肉纖維被分開以進入胸肌之間的平面，胸大肌的伸展很大。肌肉下隆胸疼痛的主要來源是肌筋膜，由胸神經(jīng)傳遞。皮膚切口可以是乳暈周圍、乳房下或腋下。與皮膚切口有關(guān)的疼痛所涉及的神經(jīng)分別是從T2到T4或從T5到T6的肋間神經(jīng)的前支和側(cè)支，或長胸神經(jīng)，有時也有一些來自鎖骨上神經(jīng)的分支，這取決于植入物的大小。
PECS是一種相對較新的筋膜平面阻滯，目的是為了在上前胸壁發(fā)揮鎮(zhèn)痛作用。PEC I以胸廓內(nèi)側(cè)和外側(cè)神經(jīng)為靶點，對胸肌進行鎮(zhèn)痛。PEC II針對肋間神經(jīng)和長胸神經(jīng)的幾個部分。這些神經(jīng)阻斷后以便在乳房手術(shù)中提供有效的鎮(zhèn)痛。
與其他描述的乳房手術(shù)技術(shù)(如椎旁阻滯)相比，PECS的并發(fā)癥更少。這些阻滯已用于乳腺癌手術(shù)期間和之后的鎮(zhèn)痛，并具有相關(guān)的鎮(zhèn)痛效果。仍然缺乏高質(zhì)量的證據(jù)支持這些方法在美容乳房手術(shù)中的鎮(zhèn)痛效果。小規(guī)模隨機對照試驗評估了用于隆胸手術(shù)的PECS，結(jié)果各不相同。
胸椎旁阻滯建議用于大型乳房手術(shù)，但不適用于隆胸手術(shù)。事實上，不完全麻醉可能是不夠的，因為來自淺頸叢、胸神經(jīng)、長胸神經(jīng)和胸背神經(jīng)的鎖骨上分支沒有被胸椎旁阻滯所阻滯。另一方面，胸椎旁阻滯涉及氣胸、脊髓損傷、交感神經(jīng)阻滯和低血壓的風(fēng)險。更罕見的是，胸椎旁阻滯可能變成硬膜外阻滯或可能導(dǎo)致全脊髓麻醉。因此，考慮到可能的副作用，它可能不適合日間手術(shù)。最近，Hussain等人進行了這項系統(tǒng)綜述和薈萃分析，確定了PECS的潛在臨床作用。他們發(fā)現(xiàn)，在乳腺癌手術(shù)后的24小時內(nèi)，兩組患者的疼痛評分或阿片類藥物消耗量沒有差異，并且兩者都優(yōu)于單獨的全身鎮(zhèn)痛。
豎脊肌平面阻滯已被提議作為計劃進行大型乳房手術(shù)的患者的PECS阻滯的替代方案。在最近的兩項研究中，作者未能證明豎脊肌平面阻滯的優(yōu)越性，在PECS組中，阿片類藥物的消耗和疼痛評分在統(tǒng)計學(xué)上顯著降低。
這項研究有幾個局限性。主要的限制是對照組沒有使用安慰劑。PECS作為筋膜間平面阻滯，需要大量的局麻藥。我們認為注射10和15ml的生理鹽水本身可能會產(chǎn)生疼痛。
· 此外，在研究(PECS程序)和一般管理(患者管理和數(shù)據(jù)記錄)中，使用不同的麻醉團隊執(zhí)行了非常嚴格的盲法程序。沒有進行皮膚冷感測試，意味著沒有確認正確的阻滯范圍。然而，冷刺激可能與用于術(shù)后疼痛的區(qū)域鎮(zhèn)痛的擴散范圍和效率相關(guān)性較差。
· 術(shù)后痛覺過敏也未得到評估。區(qū)域麻醉可有效預(yù)防痛覺過敏。這可能解釋了最后4天隨訪期間阿片類藥物消耗的差異。
· 所有手術(shù)程序都不一樣。事實上，假體可能位于胸膜前或胸膜下，這可能導(dǎo)致不同的術(shù)后疼痛。
· 136名患者接受了資格篩選，只有74名患者被隨機分組。一些患者拒絕隨機化，希望一定程度上實現(xiàn)PECS阻滯，同時，研究中的主要的整形外科醫(yī)生意外的退出了。
06
· 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.
· 術(shù)前PECS阻滯聯(lián)合推薦的多模式鎮(zhèn)痛是一種有效和安全的技術(shù)，可立即提供更好的術(shù)后鎮(zhèn)痛效果，并可進行超過5天的隨訪；此外，它與較低的阿片類藥物消耗量有關(guān)。需要進一步的研究來評估PECS預(yù)防隆乳術(shù)后慢性疼痛的臨床效果。
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