Design and application of a novel targeted puncture technique in selective lumber nerve root blocks
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摘要:背景 神经根封闭术在脊柱外科应用广泛,现存的各种术前定位、导航技术均有不足之处。目的 探讨新型椎间孔穿刺路径靶向器结合乳胶定位板在经椎间孔腰骶神经根封闭术前定位中的应用,评价其有效性和安全性。方法 回顾性分析2019年1月- 2020年2月解放军总医院第一医学中心骨科收治的腰椎退行性疾病患者99例。2019年7月之前使用乳胶定位板定位穿刺方法的病例作为A组,男22例,女25例,平均年龄(61.26±10.99)岁;2019年8月以后使用新型椎间孔穿刺路径靶向器结合乳胶定位板进行穿刺的病例作为B组,男26例,女26例,平均年龄(62.47±10.23)岁。记录两组术前穿刺次数、穿刺期透视次数、手术时间、手术并发症、穿刺术后2 h穿刺区视觉模拟评分(visual analogue scale,VAS)。分析术中实际穿刺深度和术前理论计算穿刺深度的组间差异。结果 两组患者均未出现手术并发症。A组与B组的平均穿刺次数[(4.62±1.61)次 vs (1.32±0.55)次]、平均透视次数[(7.28±2.17)次 vs (4.23±1.42)次]、手术时间[(18.15±4.80) min vs (12.79±2.80) min]、术后2 h的VAS(3.23±1.43 vs 2.46±1.11)均有统计学差异(P均<0.05)。结论 使用新型椎间孔穿刺路径靶向器结合乳胶定位板可提高穿刺的准确性,减少术前穿刺次数、透视次数、手术时间,减少医务人员和患者的辐射暴露剂量。Abstract:Background At present, selective lumber nerve root block is widely used in spinal surgery, however, preoperative positioning and navigation techniques have various shortcomings.Objective To explore the role of a new type of transforaminal puncture path targeting device combined with latex positioning plate in puncture location before selective lumber nerve root blocks, and analyze its effectiveness and safety in clinical application.Methods From January 2019 to February 2020, 99 patients (48 males and 51 females) who underwent the operation of selective lumber nerve root blocks in department of orthopedics, the First Medical Center of Chinese PLA General Hospital, were enrolled in our study. Before July 2019, latex positioning plate positioning puncture was applied to treat patients in group A, including 22 males and 25 females with an average age of 61.26±10.99 years. After July 2019, patients in group B, including 26 males and 26 females with an average age of 62.47±10.23 years, were treated with new transforaminal puncture path targeting device combined with latex positioning plate. The puncture times, fluoroscopy times, operation time and complications between the two groups were recorded and compared. The visual analogue scale (VAS) scores of the two groups were compared at 2h after operation. The differences between the actual puncture depth during operation and the theoretical puncture depth before operation were recorded and compared.Results No complications were found in the two groups. The average puncture time in group A was significantly higher than that in group B (4.62±1.61 vs 1.32±0.55, P<0.001). The average fluoroscopy times were 7.28±2.17 in group A and 4.23±1.42 in group B, with significant difference between the two groups (P<0.001). The operation duration was longer in group A compared to group B (18.15±4.80 min vs 12.79±2.80 min, P<0.001). There was significant difference in VAS scores at 2 h after operation between the two groups (3.23±1.43 vs 2.46±1.11, P<0.001).Conclusion The new type of transforaminal puncture path targeting device combined with latex positioning plate can effectively improve the accuracy of transforaminal puncture, reduce the times of puncture and fluoroscopy, operation time, and X-ray radiation of medical staff and patients.
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腰椎退行性疾病是导致腰腿痛的常见原因,以腰椎间盘突出症和腰椎管狭窄症最为多见。通常经保守治疗无效的患者需要手术治疗。退行性腰椎疾病的手术治疗趋于精准化,在精准医学背景下要求脊柱外科术前精确定位,明确责任节段,减小手术创伤,避免过度治疗[1]。通常结合病史、查体、体征、影像学检查来确定责任间隙,但部分不典型病例影像学表现为多节段病变,神经定位模糊,确定责任节段困难[2]。如单纯根据影像学结果选择狭窄节段进行减压,不仅增加手术创伤和手术费用,更破坏了腰椎稳定性,增大手术风险,加速邻近节段的退变[3]。目前神经根封闭术已广泛应用于退行性腰椎疾病的诊治[4],其对不典型腰椎退行性疾病手术节段选择有重要指导作用,尤其对侧隐窝内神经根受累的诊断作用甚佳[5]。目前临床上通常使用金属针作为经椎间孔选择性神经根封闭术的定位工具,但定位不精确。2019年6月本课题组利用穿刺靶点、穿刺靶点在皮肤上投影、穿刺进针点(P)构成空间直角三角形的原理,设计了新型椎间孔穿刺路径靶向器,并获得国家实用新型专利(专利号:ZL202020025488.4),解决了传统金属定位针定位不准确、术前准备时间长的问题。本文主要讨论了新型椎间孔穿刺路径靶向器结合乳胶定位板在经椎间孔腰骶神经根封闭术前定位中的应用,并评价其有效性和安全性。
资料与方法
1 临床资料
回顾性分析2019年1月- 2020年2月于解放军总医院第一医学中心接受选择性腰椎神经根封闭术的患者99例。纳入标准:1)腰椎间盘突出症,腰痛伴或不伴下肢的不典型放射性疼痛;2)腰椎管狭窄症,间歇性跛行,伴或不伴下肢的不典型放射性疼痛;3)腰椎间盘突出症接受经皮内镜下腰椎间盘切除术,术后复发;4)腰椎间盘突出症、腰椎滑脱症等腰椎退行性疾病,术后疼痛改善不明显。排除标准:1)伴有全身或腰椎感染、骨折、肿瘤等疾病;2)凝血功能异常;3)因疼痛严重,保持强迫体位,不能耐受局麻手术;4)严重的神经根损害症状以及马尾综合征;5)伴有严重基础疾病,心、肺、肝、肾等功能障碍不能耐受俯卧位局麻手术;6)其他影响腰椎神经根封闭术的禁忌证。符合纳入标准的患者,男51例,女48例。术前明确诊断91例,椎间孔镜术后复发2例,术后疼痛改善不明显6例。2019年7月之前符合纳入标准的患者47例,其中男22例,女25例,平均年龄(66.12±10.99)岁,使用乳胶定位板定位穿刺方法的病例作为A组。2019年8月之后符合纳入标准的患者52例,男26例,女26例,平均年龄(62.47±10.23)岁,使用新型椎间孔穿刺路径靶向器结合乳胶定位板进行穿刺的病例作为B组。两组患者术前一般情况(年龄、性别、手术节段)差异无统计学意义(P>0.05)。腰椎融合术前或者经皮椎间孔镜术前明确责任间隙(identify responsibility segments,IRS) 91例,A组43例,B组48例;缓解腰椎融合术后或经皮椎间孔镜术后的疼痛症状(relieve pain symptoms,RPS) 8例,A组4例,B组4例。见表1。
表 1 两组患者术前一般情况Table 1. Baseline characteristics of patients in the two groupsCharacteristic Group A (n=47) Group B (n=52) t/χ2 P Male/n 22 26 0.935 0.373 Age/yrs 61.26±10.99 62.47±10.23 0.669 0.818 Operative level/n 0.292 0.649 L3-L4 4 5 L4-L5 19 22 L5-S1 24 25 Operation purpose/n 0.444 0.881 IRS 43 48 RPS 4 4 2 椎间孔穿刺路径靶向器的构成
椎间孔穿刺路径靶向器由4部分链接而成:1)有角度的半圆弧带;2)可任意旋转的穿刺针导轨带;3)带有刻度的尺子;4)固定旋钮。见图1。
3 新型椎间孔穿刺路径靶向器设计原理
利用穿刺靶点(T)、穿刺靶点在皮肤上投影(A)和进针点(P)构成的空间直角三角形,设计了新型椎间孔穿刺路径靶向器(图2),结合乳胶定位板对穿刺靶点进行相关数据进行测量,计算穿刺针进针的外展角、头倾角、进针深度并对穿刺路径进行导航。
4 术前影像学测量
经椎间孔选择性腰骶椎神经根封闭术选择Kambin三角入路(图3A)。图3所示T点为椎间孔穿刺靶点,A为靶点在背部皮肤的投影,AT距离可通过MRI测量(图3C:使用Medcare影像系统),P点为穿刺进针点,PT为穿刺针进针路线,根据直角三角形定理计算∠APT的大小以及PT的长度。带刻度的直尺可测量进针点与穿刺靶点在皮肤表面投影的距离(图3C),穿刺靶点与其在皮肤表面投影距离可MRI横断面测量(图3C),进针靶点、投影点、进针点3点构成空间直角三角形,利用直角三角形定理计算出穿刺深度(穿刺进针点与穿刺靶点的距离)以及进针路径外展角。使半圆弧的圆心与进针点重合,直尺与进针点与投影点重合(图4E),调节并固定穿刺针轨道与半圆弧的角度使之等于外展角,助手固定穿刺靶向器,主刀医生使用18G穿刺针进行穿刺。
图 3 术前影像学检查A:X线上穿刺靶点;B:X线穿刺路径在皮肤表面的头倾角;C:在MRI的横断面上测量穿刺靶点至穿刺靶点在皮肤表面投影点的距离Figure 3. Imaging data of pre-operationA: the puncture target spot in X-ray radiograph; B: the head inclination angle in X-ray;C: the distance between the puncture target spot and the projection of target point on the skin in MRI图 4 定位穿刺过程A:使用G形臂进行透视;B、C:确认并标记穿刺路径的头倾角;D:测量进针点与进针靶点在皮肤表面投影点的距离;E:助手固定穿刺靶向器,主刀医生进行穿刺;F、G:正侧位X线透视显示到达穿刺靶点Figure 4. Process of the puncture locationA: using G-arm for fluoroscopy; B, C: confirm and mark the head inclination angle of the puncture path; D: measurement of the distance between the puncture entry point and the projection of puncture target spot on the skin surface; E: puncturing by using the new transforaminal puncture path targeting device; F, G: arriving the target spot5 穿刺靶点标记
A、B两组均由同一手术组医生完成,均采取Kambin三角入路。乳胶定位板中均匀加入钡剂,于X线下可显影。定位板质地柔软、坚韧,能够贴合患者背部曲线放置,可耐受常规高温消毒。其长17 cm、宽11 cm,可满足腰椎区域定位,长宽均以1 cm的网格为基本单位,使用斜线、三角、圆圈、方形等结构将网格进行分区,便于快速定位标记。乳胶定位板网格设计致密,无论靶点落在网格内还是网格连接处,均可准确定位。使用乳胶定位板进行第1次透视,确定穿刺靶点、穿刺靶点在皮肤表面的投影、进针点和穿刺路径的头倾角,用记号笔标记并取下定位板(图4B)。
6 手术方法
1)乳胶定位板组(A组):患者取俯卧位,将定位板展平置于患者腰部正中,移动G形臂进行透视(图4A),在监视器上确定目的间隙,明确并标记穿刺靶点在皮肤表面的投影(A)和进针点(P)。移除定位板,将A点、P点连线即为穿刺路径在皮肤表面的投影(图4C)。沿A点做垂直于脊柱的直线AC。AC、AP夹角α为头倾角(图3C,图4B,图4C),消毒铺巾,依照穿刺路径穿刺,调整穿刺针方向,直至正侧位透视确认穿刺针尖到Kambin三角(图4F,图4G),注射得宝松和利多卡因。2)新型椎间孔穿刺路径靶向器结合乳胶定位板组(B组):患者取俯卧位,将定位板展平置于患者腰部正中,移动G形臂进行透视(图4A),在监视器上确定目标间隙,明确并标记穿刺靶点在皮肤表面的投影A、进针点P(图4B,图4C),移除定位板,将A点、P点连线即为穿刺路径在皮肤表面的投影,使用靶向定位器直尺部分测量AP距离(图3C,图4B,图4C)。结合术前测量靶点至皮肤表面投影的距离计算出穿刺针的进针深度和外展角。进行穿刺时将靶向器半圆弧的圆心与进针点重合,直尺部分与AP连线重合,调节并固定穿刺针导轨使其等于外展角。将18G穿刺针置于导轨穿刺至预定距离,撤除靶向器进行透视直至穿刺至椎间孔靶点,注射得宝松和利多卡因。撤除穿刺针,使用靶向器直尺部分测量并记录实际进针距离。
7 观察指标
记录并比较两组患者手术过程中穿刺次数、透视次数、手术时间、并发症、术后2 h穿刺区视觉模拟评分(visual analogue scale,VAS),分析术中实际穿刺深度和术前理论计算穿刺深度的组间差异。
8 统计学分析
采用SPSS26.0软件对数据进行统计学处理,计量资料以
$ \overline x \pm s$ 表示,采用独立样本t检验,计数资料采用χ2检验,P<0.05为差异有统计学意义。结 果
两组的穿刺次数、透视次数、手术时间差异有统计学意义(P<0.05),B组均优于A组。术后2 h穿刺区域VAS评分差异有统计学意义(表2,P<0.001)。两组患者穿刺过程中的实际进针深度为(13.18±0.93) cm,与术前理论计算穿刺深度(12.85±0.90) cm比较,差异无统计学意义(P=0.066)。两组均未出现椎管内血肿、腹腔脏器损伤、下肢感觉运动异常等并发症。
表 2 新型椎间孔穿刺靶向器临床效果Table 2. Clinical outcomes of the new targeting deviceIndicator Group A
(n=47)Group B
(n=52)t P Puncture times/n 4.62±1.61 1.32±0.55 13.880 <0.001 Fluoroscopy times/n 7.28±2.17 4.23±1.42 8.324 <0.001 Operation times/min 18.15±4.80 12.79±2.80 6.873 <0.001 VAS of postoperative 2 h 3.23±1.43 2.46±1.11 3.014 <0.001 讨 论
腰椎退行性疾病治疗效果主要取决于手术减压的精确程度及减压范围[6],为确保手术效果,临床医生会选择在影像学上有压迫或退变严重的节段进行广泛减压,手术后临床症状缓解较彻底,但减压范围较大,脊柱稳定性受到破坏,手术时间较长,术中出血较多,住院时间延长,围术期并发症较多[7-9]。此外患者医疗费用增加,造成医疗资源浪费[10]。经椎间孔选择性神经根封闭手术具有神经根定位准确、操作简单、创伤小、花费少的优点,理论上可以精确定位引起老年复杂腰椎退行疾病的责任节段[11-14]。
通常使用金属针作为经椎间孔选择性神经根封闭术的定位工具,但金属针定位不精确,需反复调整透视,多次调整穿刺针会增加患者的痛苦,延长穿刺定位时间会提高硬膜囊、神经根等组织损伤风险,反复透视延长手术时间会增加医务人员和患者辐射暴露量。近年来,研究人员报道了相关穿刺定位复制设备。Fan等[15]报道了一种应用于经皮内镜下腰椎间盘切除术的定位系统,定位方法及穿刺路径设计方法与本研究相似,但术中架设该设备花费时间较长,术中定位架轻微移动会增加穿刺针调整次数。朱慧阳等[16]利用三维影像结合激光导航器辅助穿刺定位,但在操作过程中,激光导航器为固定设备,术中要求患者保持水平俯卧位,如穿刺过程中患者因疼痛等原因出现体位的变化,可能会给穿刺过程带来较大误差。本研究报道的新型靶向器具有如下优势: 1)原理简单,设计简洁,计算方法科学,穿刺精度高;2)体积小,操作灵活,适用于各个节段。
采用新型椎间孔穿刺路径靶向器结合乳胶定位板进行穿刺的B组穿刺次数、透视次数、手术时间均优于采用乳胶定位板进行穿刺的A组(P<0.05),该靶向器具有较好的穿刺准确性。新型椎间孔穿刺路径靶向器可计算并控制穿刺角及深度,能避免重复调整穿刺针所导致的术中、术后并发症。该靶向器减少了术中穿刺次数,提高了穿刺效率,且穿刺位置良好,无需进行多次调整透视,减少了辐射剂量。该靶向器主要用于经椎间孔选择性神经根封闭术,在采用椎间孔入路的手术或操作中也可应用,包括经皮椎间孔镜[17]、椎管内肿瘤活检、脊柱脓肿引流等,具体操作与前述操作无异。
新型穿刺路径定位装置结合乳胶定位板可减少经椎间孔选择性神经根封闭术中穿刺次数、透视次数和手术时间,具有良好的有效性、安全性和临床应用价值。本研究也有一些局限性,其中最重要的是回顾性研究设计和样本量较少。此外,本研究是单一中心研究,结果可能不适用于其他医疗中心。我们将继续完善经皮内镜技术辅助椎间孔穿刺定位仪的设计,继续进行大规模前瞻性临床对照试验研究,在精密医学的研究背景下进一步准确定位穿刺。
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图 3 术前影像学检查
A:X线上穿刺靶点;B:X线穿刺路径在皮肤表面的头倾角;C:在MRI的横断面上测量穿刺靶点至穿刺靶点在皮肤表面投影点的距离
Figure 3. Imaging data of pre-operation
A: the puncture target spot in X-ray radiograph; B: the head inclination angle in X-ray;C: the distance between the puncture target spot and the projection of target point on the skin in MRI
图 4 定位穿刺过程
A:使用G形臂进行透视;B、C:确认并标记穿刺路径的头倾角;D:测量进针点与进针靶点在皮肤表面投影点的距离;E:助手固定穿刺靶向器,主刀医生进行穿刺;F、G:正侧位X线透视显示到达穿刺靶点
Figure 4. Process of the puncture location
A: using G-arm for fluoroscopy; B, C: confirm and mark the head inclination angle of the puncture path; D: measurement of the distance between the puncture entry point and the projection of puncture target spot on the skin surface; E: puncturing by using the new transforaminal puncture path targeting device; F, G: arriving the target spot
表 1 两组患者术前一般情况
Table 1 Baseline characteristics of patients in the two groups
Characteristic Group A (n=47) Group B (n=52) t/χ2 P Male/n 22 26 0.935 0.373 Age/yrs 61.26±10.99 62.47±10.23 0.669 0.818 Operative level/n 0.292 0.649 L3-L4 4 5 L4-L5 19 22 L5-S1 24 25 Operation purpose/n 0.444 0.881 IRS 43 48 RPS 4 4 表 2 新型椎间孔穿刺靶向器临床效果
Table 2 Clinical outcomes of the new targeting device
Indicator Group A
(n=47)Group B
(n=52)t P Puncture times/n 4.62±1.61 1.32±0.55 13.880 <0.001 Fluoroscopy times/n 7.28±2.17 4.23±1.42 8.324 <0.001 Operation times/min 18.15±4.80 12.79±2.80 6.873 <0.001 VAS of postoperative 2 h 3.23±1.43 2.46±1.11 3.014 <0.001 -
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