[摘要] 目的 探討0.375%羅哌卡因在L形擋板干預(yù)下鎖骨上臂叢神經(jīng)阻滯(supraclavicular brachial plexus block,SCBPB)基于橫截面積(cross sectional area,CSA)用藥的半數(shù)有效量(median effective dose,ED50)。方法 選取2023年9月至2024年5月于寧波市第六醫(yī)院擇期行上肢手術(shù)的患者,隨機(jī)分為L(zhǎng)形擋板加壓組(L組)和不加壓組(C組)。通過(guò)超聲測(cè)量鎖骨上臂叢神經(jīng)CSA,并根據(jù)CSA注射0.375%羅哌卡因。采用Dixon序貫法測(cè)定,初始劑量為0.4ml/mm2,劑量梯度為0.04ml/mm2。如果30min內(nèi)阻滯有效,則下一例患者接受低一級(jí)劑量;若無(wú)效,則升一級(jí)劑量。持續(xù)該過(guò)程至出現(xiàn)7個(gè)上下交叉拐點(diǎn)(阻滯無(wú)效轉(zhuǎn)為有效)。采用Probit法計(jì)算ED50及其95%CI,并記錄膈肌麻痹、神經(jīng)損傷及呼吸困難等不良反應(yīng)。結(jié)果 C組患者0.375%羅哌卡因ED50為0.254ml/mm2(95%CI:0.228~0.278);L組患者0.375%羅哌卡因ED50為0.239ml/mm2(95%CI:0.215~0.262),組間差異無(wú)統(tǒng)計(jì)學(xué)意義(Pgt;0.05)。L組患者膈肌麻痹發(fā)生率顯著低于C組(14.29% vs. 41.67%,Plt;0.05),且未發(fā)現(xiàn)明顯的神經(jīng)損傷、呼吸困難及局麻藥中毒等并發(fā)癥。結(jié)論 基于CSA計(jì)算,L形擋板加壓下0.375%羅哌卡因用于SCBPB的ED50為0.239ml/mm2(95%CI:0.215~0.262)。L形擋板加壓可顯著降低膈肌麻痹的發(fā)生率,且無(wú)明顯副作用。
[關(guān)鍵詞] 鎖骨上臂叢神經(jīng)阻滯;羅哌卡因;半數(shù)有效量;膈肌麻痹;橫截面積
[中圖分類號(hào)] R614.4" """"[文獻(xiàn)標(biāo)識(shí)碼] A""" [DOI] 10.3969/j.issn.1673-9701.2025.18.012
ED50 of 0.375% ropivacaine for supraclavicular brachial plexus block with L-shaped pressure baffle intervention based on cross sectional area
ZHANG Liangguang1, ZHANG Long1, PANG Rufa1, QIU Wen1, ZHAO Jinsong1, QI Jianwu2
1.Department of Anesthesiology, Ningbo NO.6 Hospital, Ningbo 315040, Zhejiang, China; 2.Department of Hand Surgery, Ningbo NO.6 Hospital, Ningbo 315040, Zhejiang, China
[Abstract] Objective To explore median effective dose (ED50) of 0.375% ropivacaine based on the cross sectional area (CSA) of supraclavicular brachial plexus block (SCBPB) with L-shaped baffle intervention. Methods Patients scheduled for upper limb surgery from September 2023 to May 2024 at Ningbo NO.6 Hospital were enrolled. Patients were randomly divided into two groups: L-shaped baffle compression group (group L) and non-compression group (group C). CSA of supraclavicular brachial plexus was measured by ultrasound, and 0.375% ropivacaine was administered based on the CSA. The ED50 was determined by using the Dixon up-and-down sequential method, with an initial dose of 0.4 ml/mm2 and an incremental difference of 0.04ml/mm2. If the block was effective within 30 minutes, the next patient received a lower dose; If ineffective, a higher dose was administered. The process continued until seven cross-over points (ineffective to effective) were observed. ED50 and its 95%CI were calculated by using the Probit method. Adverse reactions, such as phrenic nerve paralysis, nerve injury, dyspnea were recorded. Results The ED50 of 0.375% ropivacaine for SCBPB in group C was 0.254 ml/mm2 (95%CI: 0.228-0.278), while in group L, it was 0.239 ml/mm2 (95%CI: 0.215-0.262), with no statistically significant difference between two groups (Pgt;0.05). The incidence of phrenic nerve paralysis in group L was significantly lower than that in group C (14.29% vs. 41.67%, Plt;0.05). No significant nerve injuries, dyspnea, or local anesthetic toxicity were observed in either group. Conclusion The ED50 of 0.375% ropivacaine for SCBPB with L-shaped baffle compression, based on the CSA of the brachial plexus, was 0.239 ml/mm2 (95%CI: 0.215-0.262). L-shaped baffle compression significantly reduced the incidence of phrenic nerve paralysis without notable side effects.
[Key words] Supraclavicular brachial plexus block; Ropivacaine; Median effective dose; Phrenic nerve paralysis; Cross sectional area
鎖骨上臂叢神經(jīng)阻滯(supraclavicular brachial plexus block,SCBPB)憑借高度集中的神經(jīng)分布和出色的阻滯效果已廣泛應(yīng)用于上肢手術(shù)[1-2];但鎖骨上臂叢神經(jīng)毗鄰鎖骨下動(dòng)脈與膈神經(jīng),行SCBPB可引發(fā)神經(jīng)毒性或局麻藥中毒,增加局麻藥劑量還可能提高膈肌麻痹的風(fēng)險(xiǎn)[3-5]。本課題組設(shè)計(jì)一種L形擋板加壓置于超聲探頭頭端,前期研究發(fā)現(xiàn)L形擋板加壓可有效減少膈肌麻痹的發(fā)生,并增強(qiáng)臂叢神經(jīng)阻滯效果[6]。研究顯示基于橫截面積(cross sectional area,CSA)計(jì)算局麻藥劑量的策略已在股神經(jīng)阻滯和坐骨神經(jīng)阻滯中取得成功,可實(shí)現(xiàn)個(gè)體化用藥并提升神經(jīng)阻滯的安全性,但在SCBPB的應(yīng)用較少[7-8]。因此,本研究旨在通過(guò)序貫法測(cè)定在L形擋板干預(yù)下,探討基于CSA給藥的0.375%羅哌卡因半數(shù)有效量(median effective dose,ED50),為臨床精準(zhǔn)用藥提供參考。
1" 資料與方法
1.1" 一般資料
選取2023年9月至2024年5月于寧波市第六醫(yī)院擇期行上肢手術(shù)的52例患者,隨機(jī)分為L(zhǎng)形擋板加壓組(L組,28例)和L形擋板不加壓組(C組,24例)。納入標(biāo)準(zhǔn):①年齡18~65歲;②美國(guó)麻醉醫(yī)師協(xié)會(huì)(American Society of Anesthesiologists,ASA)分級(jí)Ⅰ~Ⅱ級(jí);③體質(zhì)量指數(shù)(body mass index,BMI)lt;30kg/m2。排除標(biāo)準(zhǔn):①伴有臂叢神經(jīng)或膈神經(jīng)損傷者;②穿刺部位存在感染或凝血功能障礙者;③患有嚴(yán)重的全身系統(tǒng)性疾?。ㄈ绶喂δ懿蝗蛐呐K?。?;④近期服用影響神經(jīng)傳導(dǎo)的藥物或?qū)致樗庍^(guò)敏者;⑤超聲顯影質(zhì)量不佳。本研究經(jīng)寧波市第六醫(yī)院倫理委員會(huì)批準(zhǔn)(倫理審批號(hào):甬六醫(yī)倫審2023X001號(hào)),所有患者或其法定代理人均簽署知情同意書。
1.2" 分組與處理
L組患者從開(kāi)始注射局麻藥持續(xù)5min內(nèi)施加L形擋板約30N的壓力,C組患者不加壓。兩組患者的性別、年齡、ASA分級(jí)、BMI、鎖骨上臂叢神經(jīng)CSA比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(Pgt;0.05),見(jiàn)表1。采用雙盲設(shè)計(jì),患者、操作者及評(píng)估者均對(duì)分組不知情。由不參與本研究的醫(yī)師根據(jù)鎖骨上臂叢神經(jīng)的CSA用20ml注射器將0.375%羅哌卡因平均配成兩管,并用黑色不透明黏紙包裹注射器。
1.3" 麻醉方法
所有患者均按規(guī)定禁食禁飲,無(wú)術(shù)前用藥。入手術(shù)室后常規(guī)監(jiān)測(cè)生命體征,建立外周靜脈通路。患者取平臥位,頭偏對(duì)側(cè),使用SonoSite HSL25x型(6~13MHz)線陣探頭置于鎖骨上窩,定位于第1肋上方、鎖骨下動(dòng)脈外側(cè),調(diào)整探頭角度獲取臂叢神經(jīng)最佳圖像。采用超聲點(diǎn)描法測(cè)量鎖骨上臂叢神經(jīng)的CSA,每例患者測(cè)量3次取均值,見(jiàn)圖1A。消毒鋪巾后,將含耦合劑的無(wú)菌保護(hù)套包裹探頭及L形擋板,確保探頭內(nèi)側(cè)端顯示鎖骨上臂叢神經(jīng)內(nèi)側(cè)區(qū)域,由助手將擋板緊貼于探頭頭端,見(jiàn)圖1B。采用平面內(nèi)兩點(diǎn)法穿刺技術(shù),先于第1肋與鎖骨下動(dòng)脈之間的角袋處注射0.375%羅哌卡因1/2劑量,見(jiàn)圖1C。再于鎖骨上臂叢神經(jīng)上方注射剩余藥液,見(jiàn)圖1D。所有操作均由同一名不知?jiǎng)┝考胺纸M的經(jīng)驗(yàn)麻醉醫(yī)師進(jìn)行。
本研究采用Dixon序貫法設(shè)計(jì)。根據(jù)已有文獻(xiàn)報(bào)道[9]及預(yù)試驗(yàn)結(jié)果,參考鎖骨上臂叢神經(jīng)CSA,初始劑量設(shè)定為0.4ml/mm2的0.375%羅哌卡因,相鄰劑量差值為0.04ml/mm2;如果30min內(nèi)阻滯有效,則下一例患者接受低一級(jí)劑量,若無(wú)效則采用高一級(jí)劑量。持續(xù)該過(guò)程至出現(xiàn)7個(gè)有效與無(wú)效交替點(diǎn)(阻滯無(wú)效轉(zhuǎn)為有效)。
由另一名對(duì)分組不知情的麻醉醫(yī)師采用標(biāo)準(zhǔn)化方法評(píng)估肌皮神經(jīng)、橈神經(jīng)、正中神經(jīng)和尺神經(jīng)的感覺(jué)及運(yùn)動(dòng)阻滯情況,分別對(duì)應(yīng)前臂外側(cè)、手背外側(cè)、示指掌側(cè)及小指指腹。每5min評(píng)估1次,持續(xù)至30min。采用已有文獻(xiàn)中的評(píng)分標(biāo)準(zhǔn)進(jìn)行量化,滿分16分,總評(píng)分≥14分定義為阻滯完全,lt;14分視為阻滯失敗[10]。阻滯失敗者給予小劑量芬太尼20~50μg或局部浸潤(rùn),若鎮(zhèn)痛仍不足,改為全身麻醉。為避免局麻藥毒性,SCBPB的羅哌卡因最大劑量不超過(guò)40ml。
1.4" 觀察指標(biāo)
①記錄鎖骨上臂叢神經(jīng)CSA及對(duì)應(yīng)局麻藥阻滯情況。②記錄膈肌麻痹情況:術(shù)前及術(shù)后30min,用超聲“ABCDE”法測(cè)量膈肌厚度比率(diaphragm thickening fraction,DTF)。將超聲探頭置于乳頭下腋前線水平,觀察胸膜滑動(dòng)并測(cè)量膈肌厚度變化。DTFlt;5%或膈肌矛盾運(yùn)動(dòng)視為完全
麻痹;5%lt;DTFlt;20%為膈肌部分麻痹,部分麻痹和完全麻痹都被認(rèn)定為麻痹[11]。③記錄患者麻醉后出現(xiàn)的神經(jīng)損傷、聲音嘶啞、氣胸、呼吸困難及局麻藥中毒等不良情況。
1.5" 統(tǒng)計(jì)學(xué)方法
采用SPSS 26.0統(tǒng)計(jì)學(xué)軟件對(duì)數(shù)據(jù)進(jìn)行處理分析。符合正態(tài)分布的計(jì)量資料以均數(shù)±標(biāo)準(zhǔn)差(")表示,組間比較采用t檢驗(yàn);計(jì)數(shù)資料以例數(shù)(百分率)[n(%)]表示,組間比較采用Fisher確切概率法或c2檢驗(yàn)。Plt;0.05為差異有統(tǒng)計(jì)學(xué)意義。采用Probit回歸分析計(jì)算兩組患者超聲引導(dǎo)下0.375%羅哌卡因的ED50及95%CI,ED50組間比較采用U檢驗(yàn)。
2" 結(jié)果
2.1" 兩組患者的ED50比較
C組中10例患者阻滯無(wú)效,14例患者阻滯有效;L組中12例患者阻滯無(wú)效,16例患者阻滯有效,見(jiàn)圖2。C組中0.375%羅哌卡因SCBPB的ED50為0.254ml/mm2(95%CI:0.228~0.278);L組中0.375%羅哌卡因SCBPB的ED50為0.239ml/mm2(95%CI:0.215~0.262)。L組患者局麻藥用量略低,但兩組患者的ED50比較差異無(wú)統(tǒng)計(jì)學(xué)意義(Pgt;0.05)。兩組患者0.375%羅哌卡因SCBPB的劑量反應(yīng)曲線見(jiàn)圖3。
2.2" 兩組患者的并發(fā)癥發(fā)生情況比較
C組患者的膈肌麻痹發(fā)生率(10例,41.67%)高于L組(4例,14.29%),差異有統(tǒng)計(jì)學(xué)意義(χ2=4.924,P=0.026)。C組僅l例患者發(fā)生呼吸困難,經(jīng)面罩吸氧后緩解;L組1例患者發(fā)生聲音嘶啞。兩組均未出現(xiàn)局麻藥中毒、神經(jīng)損傷及氣胸等并發(fā)癥,組間差異無(wú)統(tǒng)計(jì)學(xué)意義。
3" 討論
SCBPB因其可為上肢提供高效且廣泛的麻醉,臨床應(yīng)用日益廣泛。然而,傳統(tǒng)SCBPB局麻藥用量?;诠潭▌┝炕駼MI,該方法可能存在較大誤差,增加膈肌麻痹及局麻藥毒性的風(fēng)險(xiǎn)[4-5,12-15]。研究表明外周神經(jīng)的CSA與其所需的局麻藥劑量密切相關(guān),CSA越大阻滯所需局麻藥量越多,反之亦然[8,16]。因此基于CSA計(jì)算局麻藥劑量有助于實(shí)現(xiàn)個(gè)體化用藥,提高神經(jīng)阻滯的安全性,但該方法在SCBPB中的應(yīng)用仍較少。
在SCBPB中,局麻藥主要沿肌間溝向上擴(kuò)散,部分經(jīng)椎前筋膜向內(nèi)波及膈神經(jīng)[17]。本課題組此前設(shè)計(jì)的L形擋板通過(guò)對(duì)超聲探頭頭端施壓,限制局麻藥向上向內(nèi)擴(kuò)散,并聯(lián)合“腋窩隧道”限制其向下擴(kuò)散,從而加快起效、延長(zhǎng)阻滯持續(xù)時(shí)間[6,18]。本研究中L組和C組患者的ED50分別為0.239ml/mm2和0.254ml/mm2,差異無(wú)統(tǒng)計(jì)學(xué)意義。分析原因:一是序貫法對(duì)個(gè)體解剖差異敏感,影響組間差異的顯現(xiàn)。二是CSA法所對(duì)應(yīng)的局麻藥體積較小,未加壓時(shí)注射壓力亦較低,擴(kuò)散距離有限;由于肌間溝區(qū)域結(jié)構(gòu)較為疏松,即使在未加壓情況下,局麻藥沿其鞘膜向上擴(kuò)散仍能覆蓋臂叢神經(jīng),實(shí)現(xiàn)有效阻滯,從而使兩組患者的ED50接近。此外,與以往固定劑量方案(25ml 0.375%羅哌卡因)不同,CSA指導(dǎo)下的個(gè)體化給藥可避免劑量不足或過(guò)量,進(jìn)一步減少L形擋板加壓在ED50的優(yōu)勢(shì)。綜上,L形擋板的主要作用在于引導(dǎo)局麻藥的擴(kuò)散路徑,而非僅通過(guò)減少劑量達(dá)到效果。
Pavic?i?等[19]研究發(fā)現(xiàn)不同年齡段患者的臂叢CSA差異顯著:lt;50歲組為(95±15)mm2,gt;65歲組為(51±6)mm2,對(duì)應(yīng)的ED50分別是23.0ml與11.9ml。歸因于老年人周圍神經(jīng)結(jié)構(gòu)退化及對(duì)局麻藥敏感度增加。臨床中通常將65歲作為老年人界定標(biāo)準(zhǔn),本研究納入18~65歲患者以提高結(jié)果的代表性。兩組患者的CSA值分別為(85.25±12.13)mm2和(86.07±13.06)mm2,與上述研究結(jié)果基本一致。
膈神經(jīng)麻痹是臂叢阻滯中較常見(jiàn)的并發(fā)癥。研究顯示膈神經(jīng)起于C5/C6水平,向下走行時(shí)與臂叢神經(jīng)的距離逐漸增大,SCBPB中的膈肌麻痹發(fā)生率仍可高達(dá)70%[20-21]。本研究中L組患者的膈肌麻痹發(fā)生率顯著低于C組,表明L形擋板加壓盡管低劑量局麻藥擴(kuò)散范圍縮短,但可有效控制藥液的擴(kuò)散方向,尤其是減少向膈神經(jīng)方向的擴(kuò)散,從而降低膈神經(jīng)麻痹的發(fā)生率。盡管兩組患者的ED50相似,L形擋板加壓仍具有減少膈肌麻痹的臨床價(jià)值。然而L組中仍有4例患者發(fā)生膈肌麻痹,分析原因:①加壓時(shí)間不足,松開(kāi)擋板后藥液繼續(xù)擴(kuò)散;②解剖變異,如副膈神經(jīng)的存在。副膈神經(jīng)為一種常見(jiàn)變異,約見(jiàn)于1/3人群中,起源于頸袢或鎖骨下肌神經(jīng),可能繞過(guò)擋板屏障,參與膈神經(jīng)阻滯[22]。本研究?jī)H1例患者出現(xiàn)呼吸困難,經(jīng)吸氧后緩解。有研究指出,SCBPB后約86%的患者同側(cè)膈肌功能明顯下降,且17%出現(xiàn)術(shù)后肺部并發(fā)癥[23]。因此肥胖、肺功能不全或高齡患者SCBPB應(yīng)更加警惕膈肌麻痹的風(fēng)險(xiǎn)。
本研究不足之處:①樣本量偏小,雖采用序貫法測(cè)定ED50,但更大樣本量有助于提升結(jié)果的外推性;②膈肌麻痹評(píng)估時(shí)間僅限于術(shù)后30min,難以反映其持續(xù)性及對(duì)術(shù)后恢復(fù)的影響;③局麻藥劑量雖基于CSA調(diào)整,但未充分考慮患者的體型、年齡和性別等個(gè)體差異,可能影響阻滯效果與安全;④L形擋板加壓未量化壓力,也未實(shí)現(xiàn)持續(xù)固定,后續(xù)研究可進(jìn)一步規(guī)范壓力參數(shù)以優(yōu)化阻滯效果。
本研究通過(guò)序貫法測(cè)定0.375%羅哌卡因在L形擋板干預(yù)下用于SCBPB的ED50。L形擋板加壓可顯著降低膈肌麻痹的發(fā)生率?;跈M截面積個(gè)體化用藥的方式可為SCBPB精準(zhǔn)用藥提供參考。L形擋板的應(yīng)用值得進(jìn)一步探索,以優(yōu)化局麻藥的分布與效果,減少并發(fā)癥的發(fā)生。
利益沖突:所有作者均聲明不存在利益沖突。
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(收稿日期:2024–11–02)
(修回日期:2025–06–05)
基金項(xiàng)目:浙江省寧波市鄞州區(qū)農(nóng)業(yè)與社會(huì)發(fā)展領(lǐng)域科技項(xiàng)目(2019AS0026)
通信作者:張亮光,電子信箱:lgzhang1987@163.com