Abstract
目的
探索硬膜外分娩镇痛时间对分娩镇痛中转剖宫产麻醉方式的影响。
方法
回顾性收集2019年7月~2020年6月于四川省妇幼保健院、成都市锦江区妇幼保健院接受硬膜外分娩镇痛并中转剖宫产的孕妇临床资料，根据剖宫产麻醉方式分组：硬膜外导管位置正确且镇痛良好则行硬膜外麻醉(硬膜外组)，脊髓麻醉在麻醉医生综合判断后实施(脊髓组)，即刻剖宫产以及硬膜外麻醉或脊髓麻醉失败选择全身麻醉(全麻组)。多因素Logistic逐步回归分析用于寻找影响中转剖宫产麻醉方式的风险因素。使用镇痛时间构建受试者工作曲线，通过Youden指数确定镇痛时间临界值，按临界值将孕妇分为两组，利用交叉表计算各组的相对危险度。
结果
研究共纳入820例孕妇，其中硬膜外组615例(75.0%)、脊髓组186例(22.7%)、全麻组19例(2.3%)均为即刻剖宫产，无硬膜外麻醉或脊髓麻醉失败改为全身麻醉病例。硬膜外组镇痛时间8.2±4.7 h，脊髓组镇痛时间10.6±5.1 h，全麻组镇痛时间6.7±5.2 h。Logistic回归分析显示：镇痛时间每延长1 h(OR=1.094，95% CI 1.057~1.132，P < 0.001)、术前宫口每开大1 cm(OR=1.066，95% CI 1.011~1.124，P=0.017)是硬膜外麻醉失败的独立风险因素。镇痛时间临界值为9.5 h，镇痛时间超过临界值的孕妇接受脊髓麻醉的相对风险度为1.204(95% CI 1.103~2.341，P < 0.001)。
结论
镇痛时间延长会增加硬膜外麻醉失败的风险，对镇痛时间超过9.5 h的非即刻剖宫产建议选择脊髓麻醉。
Keywords: 硬膜外分娩镇痛, 镇痛时间, 剖宫产, 麻醉方式
Abstract
Objective
To explore the effect of epidural labor analgesia duration on the outcomes of different anesthetic approaches for conversion to cesarean section.
Methods
We retrospectively collected the clinical data of pregnant women undergoing conversion from epidural labor analgesia to cesarean section at Sichuan Maternal and Child Health Hospital and Jinjiang District Maternal and Child Health Care Hospital between July, 2019 and June, 2020. For cesarean section, the women received epidural anesthesia when the epidural catheter was maintained in correct position with effective analgesia, spinal anesthesia at the discretion of the anesthesiologists, or general anesthesia in cases requiring immediate cesarean section or following failure of epidural anesthesia or spinal anesthesia. Receiver-operating characteristic curve analysis was performed to determine the cutoff value of the analgesia duration using Youden index. The women were divided into two groups according to the cut off value for analyzing the relative risk using cross tabulations.
Results
A total of 820 pregnant women undergoing conversion to cesarean section were enrolled in this analysis, including 615 (75.0%) in epidural anesthesia group, 186 (22.7%) in spinal anesthesia group, and 19 (2.3%) in general anesthesia group; none of the women experienced failure of epidural or spinal anesthesia. The mean anesthesia duration was 8.2±4.7 h in epidural anesthesia, 10.6±5.1 h in spinal anesthesia group, and 6.7 ± 5.2 h in general anesthesia group. Multivariate logistic regression analysis showed that prolongation of analgesia duration by 1 h (OR=1.094, 95% CI: 1.057-1.132, P < 0.001) and an increase of cervical orifice by 1 cm (OR=1.066, 95% CI: 1.011-1.124, P=0.017) were independent risk factors for epidural analgesia failure. The cutoff value of analgesia duration was 9.5 h, and beyond that duration the relative risk of receiving spinal anesthesia was 1.204 (95% CI: 1.103-2.341, P < 0.001).
Conclusion
Prolonged epidural labor analgesia increases the risk of failure of epidural analgesia for conversion to epidural anesthesia. In cases with an analgesia duration over 9.5 h, spinal anesthesia is recommended if immediate cesarean section is not required.
Keywords: epidural labor analgesia, analgesia duration, cesarean section, anesthesia method
硬膜外分娩镇痛是目前国内外公认最有效、最常用的分娩镇痛方法[1]，但研究表明镇痛后的孕妇有着更高中转剖宫产率[2, 3]，且剖宫产原因通常为母婴情况危急需紧急分娩，因此麻醉医生管理此类手术是极具挑战性的，其难点之一在于对硬膜外导管留置状态的孕妇选择何种麻醉方式来达到短时间开始手术、足够的镇痛完成手术以及减少麻醉并发症等目的。已有许多研究建议对存在镇痛不足、肥胖、爆破性疼痛等因素的孕妇放弃延用硬膜外导管的硬膜外麻醉，选择脊髓麻醉或全身麻醉来满足上诉条件并降低非预期麻醉变化给母婴带来的额外风险[4-6]，但镇痛时间是否影响麻醉方式尚不清楚[7, 8]。故本研究主要探索镇痛时间对中转剖宫产麻醉方式的影响，可用于指导此类手术麻醉方式选择。
1. 资料与方法
1.1. 资料来源及分组
回顾性收集2019年7月~2020年6月在四川省妇幼保健院、成都市锦江区妇幼保健院硬膜外分娩镇痛中转剖宫产的孕妇临床资料。纳入标准：1、单胎孕妇；2、ASA分级：I~II级；3、镇痛良好(中转前无VAS评分>4分或存在VAS评分>4，但在麻醉医生处理≤2次后能够获得满意效果，处理包括重新实施分娩镇痛、调整导管位置、经导管加药等)。排除标准：1、多胎孕妇；2、孕周小于37周；3、主要结局指标缺失；4、镇痛不足(中转前存在VAS评分>4，且麻醉医生处理>2次效果仍不满意)。根据剖宫产麻醉方式分组：硬膜外导管位置正确且镇痛效果良好则行硬膜外麻醉(硬膜外组)，脊髓麻醉在麻醉医生综合判断后实施(脊髓组)，即刻剖宫产以及硬膜外麻醉或脊髓麻醉失败选择全身麻醉(全麻组)。本研究已获四川省妇幼保健院伦理委员会(20210109-01)、成都市锦江区妇幼保健院伦理委员会批准(202111)。
1.2. 样本量计算
根据既往文献，预计硬膜外麻醉失败率为20%[9]，希望误差不超过3%，采用双侧检验α=0.05，利用PASS 15软件计算得到最小样本量N=715例。
1.3. 硬膜外分娩镇痛
孕妇有镇痛需求且签字同意后采用左侧卧位，穿刺点选择L2-3或L3-4椎间隙，硬膜外穿刺成功后置入普通硬膜外导管，深度4~5 cm，1%利多卡因5 mL作为试验剂量，观察10分钟孕妇无异常，使用0.08~0.1%罗哌卡因+0.4 μg/mL舒芬太尼混合液150 mL进行程控硬膜外间歇脉冲注入，首次剂量8 mL，1个脉冲/h，8 mL/脉冲，自控量5 mL，锁定时间30 min。
1.4. 剖宫产麻醉方式
1.4.1. 硬膜外麻醉
回抽导管内无脑脊液或血液，确认硬膜外导管位置正确且镇痛效果良好，经导管推注1.72%碳酸利多卡因10~12 mL，调整麻醉平面T4~T6，硬膜外麻醉成功，开始手术。
1.4.2. 脊髓麻醉
脊髓麻醉在麻醉医生综合判断后实施。患者左侧卧位，拔除分娩镇痛的硬膜外导管，选择L3-4间隙进行穿刺，单次在蛛网膜下腔推注0.5%的等比重罗哌卡因15 mg，根据情况选择是否留置硬膜外导管。如留置，则将硬膜外导管置入硬膜外腔4~5 cm。孕妇平卧后调整麻醉平面在T4~T6，开始手术。
1.4.3. 全身麻醉
根据美国妇产科医师学会"2017产科镇痛和麻醉实践指南"[10]，实施即刻剖宫产全麻标准流程为：孕妇进入手术室，按照饱胃处理，监测生命体征，面罩高流量吸氧，准备好吸引装置，以丙泊酚+罗库溴铵快速顺序诱导插管，新生儿断脐后追加其他静脉麻醉药。硬膜外麻醉或脊髓麻醉失败同样予以快速顺序诱导插管。
1.5. 观察指标
主要指标：不同麻醉方式的镇痛时间。次要指标：孕妇年龄、BMI、孕周、妊娠合并症、麻醉前是否使用缩宫素、是否人工破膜、是否镇痛不足、导管是否移位、镇痛时间、剖宫产原因、术前宫口大小、手术时间、产妇术中循环情况(收缩压 < 100 mmHg或 < 80%麻醉前基础值认为发生低血压)[11]、胎儿娩出时间、羊水性状、新生儿APGAR评分与体重、产妇术后VAS评分、产妇与产科医生满意度以及产妇住院时间等。以上资料均从电子病历收集。
1.6. 统计学分析
所有数据均使用SPSS23.0统计软件进行分析。连续型变量用独立样本t检验，用均数±标准差表示；分类变量使用卡方检验，用数值(%)表示。以麻醉方式为因变量，将单因素分析中P≤0.1的因素作为自变量纳入多因素逐步Logistic回归分析，寻找可能影响麻醉方式的风险因素。使用镇痛时间构建受试者工作曲线(ROC)，根据Youden指数找出镇痛时间临界值，并按临界值将孕妇分为两组，利用交叉表计算各组相对危险度(RR)。以P < 0.05为差异有统计学意义。
2. 结果
2.1. 一般资料及术前指标
2019年7月~2020年6月两院共实施硬膜外分娩镇痛4428例，根据纳入和排除标准，最终筛选出820例孕妇，其中硬膜外组615例(75.0%)、脊髓组186例(22.7%)、全麻组19例(2.3%)均为即刻剖宫产，无硬膜外麻醉或脊髓麻醉失败改为全身麻醉病例，故本研究主要分析硬膜外组与脊髓组差异。单因素分析显示，硬膜外组与脊髓组孕妇在年龄、BMI、孕周、麻醉前是否使用缩宫素、剖宫产主要原因、孕妇合并症等方面差异无统计学意义(P>0.05)；硬膜外组镇痛时间小于脊髓组(8.2± 4.7 h vs 10.6±5.1 h)、术前宫口小于脊髓组(4.2±3.1 cm vs 5.1 ± 3.3 cm)、导管脱出比例小于脊髓组(0% vs 11.3%)，差异具有统计学意义(P < 0.01，表 1)。
表 1.
产妇术前指标
Patient characteristics of the women before cesarean section
| Parameter | Group ESA(n=615) | Group SA(n=186) | Group GA(n=19) | ALL(n=820) | P of ESA and SA |
| ESA: Epidural surgery anesthesia; SA: Spinal anesthesia; GA: General anesthesia; BMI: Body mass index; ARM: Artificial rupture of membranes; FD: Fetal distress; RCD: Relative cephalopelvic disproportion; ELA: Epidural labor analgesia; SCO: Size of cervical orifice before operation | |||||
| Age (year) | 29.1±3.6 | 28.9±3.7 | 29.0±4.0 | 29.0±3.6 | 0.46 |
| BMI (kg/m2) | 26.9±2.9 | 27.1±3.5 | 26.5±3.0 | 26.9±3.0 | 0.42 |
| Gestational age (week) | 39.5±1.2 | 39.4±1.2 | 39.1±1.6 | 39.4±1.2 | 0.55 |
| ARM [n(%)] | 176(28.6) | 37(19.9) | 3(15.8) | 216(27.0) | 0.02 |
| Oxytocin used before anesthesia [n(%)] | 296(48.1) | 87(46.8) | 13(68.4) | 396(48.3) | 0.75 |
| Catheter extrusion [n(%)] | 0(0) | 2(11.3) | / | 21(2.6) | < 0.01 |
| Causes of cesarean section [n(%)] | |||||
| FD | 216(35.1) | 62(33.3) | 12(63.2) | 290(35.3) | 0.65 |
| RCD | 136(22.1) | 40(21.5) | 0(0) | 176(21.5) | 0.86 |
| Complications [n(%)] | |||||
| Diabetes | 132(21.5) | 30(16.1) | 2(10.5) | 164(20.0) | 0.11 |
| Thyroid disease | 44(7.2) | 10(5.4) | (5.3) | 55(6.7) | 0.40 |
| Hypertension | 59(9.6) | 25(13.4) | (5.3) | 85(10.4) | 0.13 |
| ELA duration (h) | 8.2±4.7 | 10.6±5.1 | 6.7±5.2 | 8.7±4.9 | < 0.01 |
| SCO (cm) | 4.2±3.1 | 5.1±3.3 | 5.1±3.7 | 4.4±3.2 | < 0.01 |
2.2. 手术麻醉情况及术后情况
硬膜外组与脊髓组破水时间、手术时间、胎儿娩出时间、羊水性状差异无统计学意义(P>0.05)；硬膜外组发生低血压产妇比例小于脊髓组(23.1% vs 32.3%，表 2)。两组新生儿出生后1、5、10 min平均APGAR评分、新生儿体重、产妇术后VAS评分、产妇与产科医生满意度以及产妇住院天数差异无统计学意义(P>0.05，表 3)。
表 2.
麻醉与手术情况
Anesthesia and surgical data of the women
| Data | Group ESA (n=615) | Group SA(n=186) | Group GA (n=19) | ALL (n=820) | P of ESA and SA |
| ESA: Epidural surgery anesthesia; SA: Spinal anesthesia; GA: General anesthesia; BT: Time of breaking-water; OT: Operation time; DT: Delivery time; CAF: Character of amniotic fluid. | |||||
| BT (h) | 17.5±15.6 | 19.0±15.3 | 15.5±14.1 | 17.8±15.5 | 0.20 |
| OT (min) | 40.4±12.0 | 40.4±11.5 | 40.0±12.4 | 40.4±11.9 | 0.95 |
| DT (min) | 4.2±2.0 | 4.4±3.3 | 3.0±1.4 | 4.2±2.4 | 0.39 |
| Hypotension | 142(23.1) | 60(32.3) | 10(52.6) | 212(25.9) | 0.01 |
| CAF n(%) | |||||
| Fecal staining | 238(36.2) | 77(34.4) | 4(21.0) | 319(35.4) | 0.63 |
| Clear | 398(60.6) | 141(62.9) | 12(63.2) | 55(61.2) | 0.58 |
| Bloodiness | 20(3.0) | 4(1.8) | 3(15.8) | 27(3.0) | 0.48 |
表 3.
术后情况
Postoperative data of the women
| Data | Group ESA(n=615) | Group SA (n=186) | Group GA (n=19) | ALL (n=820) | P of ESA and SA |
| ESA: Epidural surgery anesthesia; SA: Spinal anesthesia; GA: General anesthesia; VAS: Visual analogu scale. | |||||
| APGAR score | |||||
| 1 min | 9.88±0.56 | 9.92±0.36 | 9.34±0.71 | 9.88±0.53 | 0.36 |
| 5 min | 9.99±0.15 | 9.99±0.13 | 9.83±0.22 | 9.98±0.14 | 0.90 |
| 10 min | 9.99±0.09 | 9.99±0.10 | 10.00±0.00 | 9.99±0.09 | 0.74 |
| Neonatal weight (g) | 3395.0±356.1 | 3434.6±340.4 | 3261.5±405.1 | 3374.0±367.67 | 0.18 |
| VAS score of puerpera | 2.9±1.5 | 2.2±1.2 | 4.0±0.8 | 2.7±1.5 | 0.10 |
| Satisfaction of puerpera n (%) | |||||
| Satisfaction | 574(93.3) | 168(90.3) | 9(47.4) | 751(91.6) | 0.17 |
| Relative satisfaction | 34(5.5) | 15(8.1) | 6(31.5) | 55(6.7) | 0.21 |
| Non-satisfaction | 7(1.2) | 3(1.6) | 4(21.1) | 14(1.7) | 0.89 |
| Satisfaction of obstetricians n (%) | |||||
| Satisfaction | 542(88.1) | 171(91.9) | 19(100) | 732(89.3) | 0.15 |
| Relative satisfaction | 72(11.7) | 15(8.1) | 0(0) | 87(10.6) | 0.16 |
| Non-satisfaction | 1(0.2) | 0(0) | 0(0) | 1(0.1) | 1 |
| Days in hospital (days) | 6.6±2.4 | 6.6±1.7 | 8.3±1.8 | 6.9±2.0 | 0.98 |
2.3. 多因素logistic分析
将镇痛时间、术前宫口大小及人工破膜纳入多因素逐步向前Logistic回归模型，结果显示：镇痛时间每延长1 h(OR=1.094，95% CI 1.057~1.132，P < 0.001)、术前宫口每开大1 cm(OR=1.066，95% CI 1.011~1.124，P= 0.017)是硬膜外麻醉失败的独立风险因素，而人工破膜则(OR=0.603，95%CI 0.399~0.912，P=0.017)促进硬膜外麻醉成功(表 4)。
表 4.
影响麻醉方式相关因素的多因素Logistic回归分析
Multivariate logistic regression analysis of the factors affecting the choice of anesthetic method
| Factor | B | S χ2 | Wald χ2 | OR | OR 95% CI | P |
| ELA: Epidural labor analgesia; ARM: Artificial rupture of membranes. | ||||||
| Per hour prolongation of ELA | 0.089 | 0.018 | 26.057 | 1.094 | 1.057~1.132 | < 0.001 |
| Per cm increase in cervical orifice | 0.064 | 0.027 | 5.748 | 1.066 | 1.011~1.124 | 0.017 |
| ARM | -0.506 | 0.211 | 5.661 | 0.603 | 0.399~0.912 | 0.017 |
2.4. ROC曲线及RR
使用镇痛时间构建ROC曲线，曲线下面积为0.63，临界值为9.5 h，在Youden指数(0.183)处，特异性为66.7%，敏感性为51.6%(图 1)。按临界值分组显示(表 5)：镇痛时间≥9.5 h组脊髓麻醉的比例(31.9%)高于镇痛时间 < 9.5 h组(18.0%)。与镇痛时间 < 9.5 h组相比，镇痛时间≥9.5 h组接受脊髓麻醉的RR为1.204(95% CI= 1.103~2.341，P < 0.01)。
图 1.
镇痛时间ROC曲线
ROC of epidural labor analgesia duration.
表 5.
不同镇痛时间组的RR
Relative risks in groups with different ELA durations
| ELA duration | n | Group ESA (n=615) | Group SA (n=186) | RR | 95% CI | P |
| ESA: Epidural surgery anesthesia; SA: Spinal anesthesia; ELA: Epidural labor analgesia. | ||||||
| > 9.5 h | 301 | 205(68.1%) | 96(31.9%) | 1.204 | 1.103~2.341 | < 0.001 |
| < 9.5 h | 500 | 410(82.0%) | 90(18.0%) | 0.564 | 0.440~0.724 | < 0.001 |
3. 讨论
产科全麻仍是母婴死亡的独立危险因素，而非计划的全身麻醉会进一步增加母婴风险[12]。在一些常规沿用硬膜外麻醉的研究中，全麻率为5%~19.8%[13-15]，均高于中转剖宫产全麻率 < 5%[16]的要求，故国外许多麻醉医生强烈赞成减少甚至停止硬膜外分娩镇痛向硬膜外麻醉的转化，直接实施脊髓麻醉，即使镇痛效果良好[17, 18]。然而盲目的放弃硬膜外麻醉不但增加麻醉医生工作量，还可能提高穿刺失败率延误手术进程。因此如何尽早判断可能失败的硬膜外麻醉是中转剖宫产麻醉方式选择的关键，本研究发现除外镇痛不足、肥胖、爆破性疼痛等因素，对于镇痛时间超过9.5 h的孕妇也应放弃硬膜外麻醉。
导管在位是硬膜外麻醉成功的基本条件，而本研究中导管移位病例均在镇痛时间较长的脊髓组，与Riley团队发现的硬膜外导管移位风险随着镇痛时间延长逐渐上升规律一致，其可能原因包括更多的体动、胶带固定失效等[19, 20]。同时，镇痛时间延长会增加相同条件下的给药次数与用药量，导致硬膜外腔中大量低浓度液体稀释术前推注的药物，硬膜外麻醉失败的风险随之升高[12]。长时间未分娩还易造成孕妇焦虑，此现象在剖宫产孕妇尤其是急诊剖宫产孕妇中更常出现，而过分焦虑带来的结果是耐痛阈降低，用药量进一步增加[21, 22]。按常规的产程进展，在镇痛后9.5 h孕妇往往处于潜伏期向活跃期过渡阶段或者已在活跃期，此时易发生镇痛不足与爆破性疼痛，同样会增加孕妇对镇痛的需求，而宫口不断扩大也有着相似的效应[23, 24]。在赵娜[25]等的研究中，镇痛时间较长组不但在总的用药量上明显多于镇痛时间较短组，并且在单位时间内的用药量也明显多于镇痛时间较短组(P=0.002)，其原因或许与镇痛时间延长造成的焦虑、镇痛不足与爆破性疼痛易发相关。因此，对于镇痛时间较长的孕妇硬膜外麻醉往往会失败，需选择脊髓麻醉，而人工破膜促进硬膜外麻醉成功的关键可能在于其能够加速产程进展，缩短镇痛时间，进而减小了导管移位的概率与硬膜外液体容量[26]。
另外，鉴于在经导管给药但硬膜外麻醉失败后30 min内行脊髓麻醉与严重产科麻醉并发症相关，包括将硬膜外未扩散的液体误认为脑脊液导致腰麻失败；硬膜外原有的局麻药从穿刺孔漏入蛛网膜下腔和/或脑脊液中的局麻药被大量硬膜外液体挤向头侧而发生高位脊麻[27-29]，麻醉医生更应提前判断硬膜外麻醉的成功与否，尽可能避免在硬膜外推注后立即实施脊髓麻醉，然而当其发生不可避免，较低局麻药剂量以及延迟仰卧位可能对高位脊麻有预防作用[30]。
本研究仍有局限性：第一、没有关于单侧阻滞的数据，因为单侧阻滞也可能提示镇痛不足[31]。第二、本研究中转剖宫产率为18.5%(820/4428)，偏高，说明产科在剖宫产指证掌握上有些宽松，导致真实例数可能存在偏差。第三、ROC曲线下面积为0.63，特异性为66.7%，敏感性为51.6%，敏感性和特异性不够高，可能是样本量不足所致。
综上，我们建议麻醉医生加强分娩镇痛期间的随访，与产科医师、助产士建立良好的沟通，及时处理镇痛不足的病例，并为确定中转剖宫产的孕妇尽早行麻醉方式评估，对镇痛时间超过9.5 h的非即刻剖宫产建议选择脊髓麻醉。
Biography
朱思颖，硕士，医师，E-mail: 2456213334@qq.com
Funding Statement
四川省省卫计委课题(17PJ239)
Contributor Information
朱 思颖 (Siying ZHU), Email: 2456213334@qq.com.
张 健 (Jian ZHANG), Email: anesthesiologyzj@foxmail.com.
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