中国医科大学学报  2022, Vol. 51 Issue (1): 54-58, 64

文章信息

那琦, 冯娅妮
NA Qi, FENG Yani
经产妇不同剂量舒芬太尼蛛网膜下腔阻滞的分娩镇痛效果比较
Comparison of the analgesic effects of the subarachnoid block with different doses of sufentanil in parturient women
中国医科大学学报, 2022, 51(1): 54-58, 64
Journal of China Medical University, 2022, 51(1): 54-58, 64

文章历史

收稿日期:2021-01-29
网络出版时间:2021-12-27 20:33
经产妇不同剂量舒芬太尼蛛网膜下腔阻滞的分娩镇痛效果比较
那琦1 , 冯娅妮2     
1. 中国医科大学北部战区总医院麻醉科, 沈阳 110002;
2. 中国医科大学附属第一医院麻醉科, 沈阳 110001
摘要目的 探讨不同剂量舒芬太尼蛛网膜下腔阻滞用于经产妇分娩镇痛的有效性和安全性。方法 收集2019年3月至10月于中国医科大学北部战区总医院产科就诊的90例行分娩镇痛经产妇的临床资料。本研究获得医院伦理委员会批准,患者均知情同意并签署知情同意书。采用随机数字表法分为3组:连续硬膜外分娩镇痛组(对照组,药液为0.1%罗哌卡因+0.33%舒芬太尼100 mL,首次剂量12 mL,背景剂量3 mL,自控剂量10 mL,锁时30 min)、舒芬太尼5 μg组[单次5 μg舒芬太尼蛛网膜下给药且留置硬膜外导管,连接硬膜外自控镇痛(PCEA)泵。药液为0.1%罗哌卡因+0.33%舒芬太尼100 mL,仅设自控给药,15 mL/次,锁时30 min];舒芬太尼7.5 μg组(7.5 μg舒芬太尼蛛网膜下给药且留置硬膜外导管,连接PCEA泵。药液及设置同舒芬太尼5 μg组)。比较各组产妇实施分娩镇痛后VAS评分 < 3分所用的时间,给药至宫口开全时间,PCEA泵药总量,给药后30 min、60 min VAS评分,宫口开全时VAS评分;新生儿Apgar评分、脐动脉血pH值;产妇第二产程时间,宫口开全时改良Bromage评分,药物不良反应(恶心、皮肤瘙痒、呕吐、尿潴留、下肢麻木等)发生情况。结果 舒芬太尼7.5 μg组镇痛药物起效时间最短,且舒芬太尼5 μg组、舒芬太尼7.5 μg组达到VAS评分 < 3分所用时间明显少于对照组(P < 0.01)。与对照组、舒芬太尼5 μg组比较,舒芬太尼7.5 μg组给药到宫口开全时间差异均有统计学意义(P < 0.001),而对照组、舒芬太尼5 μg组比较差异无统计学意义(P=0.954)。PCEA泵注药量舒芬太尼7.5 μg组显著少于对照组、舒芬太尼5 μg组(P < 0.01)。3组给药后30 min时VAS评分比较差异有统计学意义(P < 0.001),舒芬太尼7.5 μg组VAS评分明显低于对照组(P < 0.001),而舒芬太尼5 μg组、舒芬太尼7.5 μg组比较无统计学差异(P=0.632)。3组给药后60 min时VAS评分差异有统计学意义(P < 0.001),其中对照组、舒芬太尼5 μg组VAS评分均高于舒芬太尼7.5 μg组(均P < 0.001)。3组宫口全开时VAS评分差异有统计学意义(P < 0.001),与对照组、舒芬太尼5 μg组比较,舒芬太尼7.5 μg组VAS评分明显降低(均P < 0.001)。3组产妇第二产程时间、血气pH、宫口开全时改良Bromage评分,新生儿1、5、10 min Apgar评分比较差异均无统计学意义(均P>0.05)。与对照组、舒芬太尼5 μg组比较,舒芬太尼7.5 μg组下肢麻木、恶心、尿潴留发生率明显减少(均P < 0.05),而对照组、舒芬太尼5 μg组间比较无统计学差异(均P>0.05)。结论 宫口≥ 3 cm以上的经产妇分娩时可优先选用7.5 μg舒芬太尼蛛网膜下给药的分娩镇痛方式。
关键词舒芬太尼    经产妇    分娩镇痛    
Comparison of the analgesic effects of the subarachnoid block with different doses of sufentanil in parturient women
NA Qi1 , FENG Yani2     
1. Department of Anesthesiology, General Hospital of Northern Theater Command, China Medical University, Shenyang 110002, China;
2. Department of Anesthesiology, The First Hospital of China Medical University, Shenyang 110001, China
Abstract: Objective To explore the effectiveness and safety of the subarachnoid block with different doses of sufentanil for analgesia during labor. Methods We collected the clinical data of 90 women who had received labor analgesia in the Department of Obstetrics, General Hospital of Northern Theater Command, China Medical University, from March to October 2019. This study was approved by our hospital's ethics committee, and informed consent forms were signed by each patient. The patients were divided into three groups using the random number table method: the continuous epidural labor analgesia group (control group in which the preparation solution was 0.1% ropivacaine + 0.33% sufentanil 100 mL, the first dose was 12 mL, the background dose was 3 mL, the self-control dose was 10 mL, and the lock time was 30 min); the sufentanil 5 μg group[involving a single 5 μg sufentanil subarachnoid administration with an indwelling epidural catheter, connected to a patient controlled epidural analgesia (PCEA) pump, the drug solution was 0.1% ropivacaine + 0.33% sufentanil 100 mL, only set self-controlled drug delivery, 15 mL/time, lock time for 30 min]; and the sufentanil 7.5 μg group (7.5 μg subarachnoid sufentanil administration via an indwelling epidural catheter, connected to a PCEA pump, the drug solution and settings were the same as those of the sufentanil 5 μg group). We compared the time taken for each group to attain parturient analgesia with VAS scores < 3. The time from administration to the opening of the cervix; the total amount of PCEA pumps; the VAS scores at 30 and 60 min after the administration; the opening of the cervix; the full-time VAS score; the Apgar score of the newborns; the pH value of the umbilical arterial blood; time of the second stage of labor; modified Bromage score of the full-time cervical opening; and adverse drug reactions (nausea, skin pruritus, vomiting, urinary retention, numbness of lower limbs, etc.) were all noted. Results the sufentanil 7.5 μg group had the shortest onset time, and the time it took for the sufentanil 5 and 7.5 μg groups to attain VAS scores < 3 was significantly less than that of the control group (P < 0.01). From the administration to the full opening of the cervix, the difference between the sufentanil 7.5 μg group, and the control and sufentanil 5 μg groups, was statistically significant (P < 0.001), while the difference between the control and sufentanil 5 μg groups was not statistically significant (P=0.954). The PCEA pump injection dose of the sufentanil 7.5 μg group was significantly lower than that of the control and sufentanil 5 μg groups (P < 0.01). There was a statistically significant difference in the VAS scores of the three groups at 30 min after analgesia (P < 0.001). The VAS score of the sufentanil 7.5 μg group was significantly lower than that of the control group (P < 0.001). There was no significant difference between the sufentanil 5 and 7.5 μg groups (P=0.632). The VAS scores of the three groups at 60 min after analgesia were significantly different (P < 0.001), and those of the control and sufentanil 5 μg groups were higher than those of the sufentanil 7.5 μg group (all P < 0.001). There was a statistically significant difference in the VAS scores of the three groups when the cervix was fully opened (P < 0.001). Compared with the control and sufentanil 5 μg groups, the VAS score of the sufentanil 7.5 μg group was significantly lower (all P < 0.001). There were no significant differences in the time of the second labor, blood gas pH, and full-time uterine opening between the three groups. The Apgar scores of the newborns at 1, 5, and 10 minutes were not statistically different (all P>0.05). Compared with that in the control and 5 μg sufentanil groups, the incidence of lower limb numbness, nausea, and urinary retention was significantly reduced in the sufentanil 7.5 μg group (all P < 0.05). There was no statistical difference between the control and sufentanil 5 μg groups (all P>0.05). Conclusion When a cervix ≥ 3 cm gives birth, the subarachnoid administration of sufentanil (7.5 μg) is the preferred method of inducing labor analgesia.
Keywords: sufentanil    multipara    analgesia during labor    

产妇分娩期间经受的剧烈疼痛常导致产妇出现紧张、焦虑、恐惧等心理[1]。产妇头胎为顺产,二胎仍顺产时产程时间短,宫缩痛剧烈。针对经产妇特点做出快速、行之有效的分娩镇痛,是麻醉医生急需解决的问题。

目前,使用最广泛的分娩镇痛方式是连续硬膜外阻滞,常用方式为罗哌卡因复合镇痛药舒芬太尼联合阻滞,但存在起效慢、大剂量易出现腿部麻木及第二产程无力的弊端。本研究探讨不同剂量舒芬太尼蛛网膜下阻滞用于经产妇分娩镇痛的有效性和安全性,旨在为临床上经产妇实施有效的分娩镇痛提供参考。

1 材料与方法 1.1 临床资料及分组

收集2019年3月至10月于中国医科大学北部战区总医院产科行分娩镇痛经产妇的临床资料。纳入标准:(1)初产为顺产的经产妇且间隔≤5年;(2)年龄29~35岁;(3)ASA分级为Ⅰ级和Ⅱ级;(4)孕周36~41周;(5)单胎;(6)经产科医生及助产士评估可顺产;(7)宫口≥3 cm并有规律宫缩;(8)自愿行分娩镇痛且无椎管穿刺禁忌证。排除标准:(1)不能配合椎管麻醉;(2)无法配合评分;(3)分娩镇痛期间转为剖宫产;(4)患有严重心、脑、肝、肾等疾病。本研究获得医院伦理委员会批准,患者知情同意并签署知情同意书。

共纳入90例,采用随机数字表法随机分为3组:对照组、舒芬太尼5 μg组、舒芬太尼7.5 μg组,每组30例。3组产妇年龄、身高、体质量、二胎间隔时间、孕周、宫口开大程度比较差异无统计学意义(均P > 0.05),具有可比性。见表 1

表 1 3组患者一般资料比较 Tab.1 Comparison of the general information of three patient groups
Group Age(year) Height(cm) Weight(kg)
Control 31.90±2.30 162.87±5.14 78.30±5.39
sufentanil 5 μg 31.50±1.50 163.57±5.25 78.17±7.22
sufentanil 7.5 μg 32.43±2.00 162.30±4.73 77.70±7.72
Group Time between second births(year) Gestational week(week) Uterine opening degree(cm)
Control 2.67±1.00 38.40±1.19 3.13±0.43
sufentanil 5 μg 2.53±0.90 38.53±1.20 3.07±0.25
sufentanil 7.5 μg 2.83±0.95 38.37±1.00 3.10±0.40

1.2 镇痛方法

1.2.1 对照组

采用连续硬膜外分娩镇痛,产妇侧卧位,L3~4间隙行硬膜外穿刺并置管,留置硬膜外腔3 cm,配制药液为0.1%罗哌卡因(H20140763,瑞典AsteaZeneca公司)+0.33%舒芬太尼(01A06151,人福医药集团有限公司)100 mL,首次剂量为12 mL,背景剂量为3 mL,自控剂量10 mL,锁时30 min。

1.2.2 舒芬太尼5 μg组

产妇侧卧位,L3~4间隙行硬膜外穿刺后,单次腰麻针蛛网膜下腔给予5 μg舒芬太尼(50 μg舒芬太尼稀释到10 mL,取1 mL),并留置硬膜外导管,连接硬膜外自控镇痛(patient controlled epidural analgesia,PCEA)泵(药液为0.1%罗哌卡因+ 0.33%舒芬太尼100 mL,仅设自控给药,15 mL/次,锁时30 min)。

1.2.3 舒芬太尼7.5 μg组

产妇侧卧位,L3~4间隙行硬膜外穿刺后,单次腰麻针蛛网膜下给与7.5 μg舒芬太尼(50 μg舒芬太尼稀释10 mL,取1.5 mL),留置硬膜外导管,连接PCEA泵(药液为0.1%罗哌卡因+0.33%舒芬太尼100 mL,仅设自控给药,15 mL/次,锁时30 min)。

1.3 观察指标

观察各组产妇实施分娩镇痛后视觉模拟评分法(visual analogue scale,VAS)评分 < 3分所用的时间[2],给药到宫口开全时间,PCEA泵药总量;给药后30 min、60 min VAS评分,宫口开全时VAS评分;新生儿Apgar评分[3]、脐动脉血pH值[4],第二产程时间;开全时改良Bromage评分[5],药物不良反应(恶心、皮肤瘙痒、呕吐、尿潴留、下肢麻木等)发生情况。

1.4 统计学分析

采用SPSS 25.0软件进行统计学分析。计量资料采用x±s表示,满足正态性及方差齐性的组间比较采用单因素方差分析;不满足正态性或方差齐性的组间比较采用Kruskal Wallis H检验。组间差异有统计学意义时,采用Dunnett法进行两两比较。计数资料采用率(%)表示,组间比较采用χ2检验或Fisher确切概率法。P < 0.05为差异有统计学意义。

2 结果 2.1 3组镇痛效果比较

结果显示,与对照组、舒芬太尼5 μg组比较,舒芬太尼7.5 μg组药物起效时间、宫口给药到开全时间明显缩短,PCEA泵注药量明显减少,差异均有统计学意义(均P < 0.01),见表 2

表 2 3组镇痛效果比较 Tab.2 Comparison of the analgesic effects in the three groups
Group Time of VAS < 3(s) Time from administration to opening of the cervix(min) Total pump drug(mL)
Control 859.17±118.48 165.00±29.97 57.90±9.92
sufentanil 5 μg 236.10±57.421) 156.67±23.87 29.23±9.691)
sufentanil 7.5 μg 89.45±42.571),2) 131.48±31.541),2) 01),2)
1)P < 0.001 compared with control group;2)P < 0.001 compared with sufentanil 5 μg group.

VAS评分结果显示,3组给药后30 min时VAS评分差异有统计学意义(F = 19.681,P < 0.001),其中舒芬太尼7.5 μg组VAS评分明显低于对照组(P < 0.001);VAS评分对照组、舒芬太尼5 μg组比较差异有统计学意义(P < 0.001),而舒芬太尼5 μg组、舒芬太尼7.5 μg组比较无统计学差异(P = 0.632)。3组给药后60 min时VAS评分差异有统计学意义(H = 62.966,P < 0.001),对照组、舒芬太尼5 μg组VAS评分均高于舒芬太尼7.5 μg组(均P < 0.001),而对照组、舒芬太尼5 μg组之间差异无统计学意义(P = 0.439)。3组宫口全开时VAS评分差异有统计学意义(H = 74.841,P < 0.001),与对照组、舒芬太尼5 μg组比较,舒芬太尼7.5 μg组VAS评分明显降低(均P < 0.001),而对照组、舒芬太尼5 μg组之间差异无统计学意义(P = 1.000),见表 3

表 3 3组给药后30 min、60 min时及宫口全开时VAS评分比较 Tab.3 Comparison of the VAS scores in the three groups at 30 min and 60 min after delivery analgesia and at full cervical opening
Group 30 minutes after analgesia 60 minutes after analgesia Full cervical opening
Control 2.23±0.68 2.40±0.50 3.10±0.31
sufentanil 5 μg 1.60±0.501) 2.07±0.58 3.20±0.41
sufentanil 7.5 μg 1.53±0.571) 0.41±0.501),2) 1.14±0.351),2)
1)P < 0.001 compared with control group;2)P < 0.001 compared with sufentanil 5 μg group.

2.2 3组新生儿Apgar评分、第二产程时间和血气pH比较

结果显示,3组新生儿出生1 min、5 min Apgar评分,第二产程时间和血气pH比较差异均无统计学意义(均P > 0.05),见表 4。3组新生儿出生10 min Apgar评分均为10分。

表 4 3组分娩情况比较 Tab.4 Comparison of the three components of delivery in the three groups
Group Neonatal Apgar score The second stage of labor(min) pH
1 min 5 min
Control 9.80±0.61 9.93±0.25 9.17±1.74 7.25±0.03
Sufentanil 5 μg 9.80±0.61 10.00±0 8.66±1.98 7.25±0.03
Sufentanil 7.5 μg 9.93±0.26 10.00±0 8.24±2.16 7.24±0.04
F 0.390 4.045 1.677 0.535
P 0.823 0.132 0.193 0.587

2.3 3组不良反应发生情况比较

结果显示,3组改良Bromage评级比较差异无统计学意义(P = 0.318)。与对照组、舒芬太尼5 μg组比较,舒芬太尼7.5 μg组下肢麻木、恶心、尿潴留发生率明显减少(均P < 0.05),而对照组、舒芬太尼5 μg组比较无统计学差异(均P > 0.05)。见表 5

表 5 3组不良反应发生情况比较 Tab.5 Comparison of the occurrence of adverse reactions in the three groups
Group Improved Bromage rating Numbness in lower limbs Nausea Vomiting Itchy skin Urinary retention
Level 0 Level 1 Level 2 Level 3
Control 27 3 0 0 81) 41) 1 4 71)
Sufentanil 5 μg 29 1 0 0 61) 61) 1 6 51)
Sufentanil 7.5 μg 30 0 0 0 0 0 0 7 0
1)P < 0.05 vs compared with sufentanil 7.5 μg group.

3 讨论

临床上腰硬联合麻醉具有起效迅速,麻醉效果确切,减少麻醉药物用量等优点,有效避免了持续给药时由于个体差异而引起的药物过量问题,从而确保了患者早日恢复正常运动功能,并且符合“快速康复”理念。舒芬太尼具有易通过血脑屏障及细胞膜、亲脂性高等特点,具有麻醉起效快、镇痛效果好、持续时间长等优点,且对血流动力学影响弱,小剂量使用患者呼吸抑制、恶心呕吐、皮肤瘙痒等不良反应发生率低,镇痛效果是芬太尼的四倍多,因此是目前理想的分娩镇痛药物之一[6-7]。已有研究[8-9]发现,经产妇分娩过程中中度疼痛发生率明显低于初产妇。与初产妇比较,经产妇宫颈管较短,第一产程平均为6~8 h,第二产程一般在1 h以内,宫颈扩张比较快,宫缩强度更大、急产率高,并且经产妇常伴有产前焦虑恐惧。因此,采取起效迅速、用药量少、作用时间短等腰硬联合麻醉下分娩镇痛对于经产妇更有优势。

本研究结果显示,经产妇实施腰硬联合麻醉阵痛效果更佳,镇痛所需时间缩短;7.5 μg舒芬太尼能产生较好的镇痛效果,具有减少药物泵入、不良反应少、对胎儿影响小等优点。VÄÄNÄNEN等[10]研究舒芬太尼和芬太尼在腰硬联合麻醉下20 min中内对孕妇分娩镇痛的影响,选用的舒芬太尼剂量为5 μg,其原因是经产妇舒芬太尼半数有效量(median effective dose 50,ED50)和95%的有效药物剂量(median effective dose 95,ED95)的剂量分别是2.6 μg和8.9 μg。MANOUCHEHRIAN等[11]研究舒芬太尼对分娩镇痛的效果所选用的剂量为7.5 μg,结果显示该剂量安全性高、起效迅速,并且镇痛时间长。因此本研究选择舒芬太尼剂量(5 μg、7.5 μg)在安全范围之内。

本研究结果显示,与对照组、舒芬太尼5 μg组比较,舒芬太尼7.5 μg组减少麻醉药物的用量、降低经产妇疼痛,并且缩短第二产程和宫口开全所用的时间,减少经产妇分娩过程中不良反应的发生,表明在蛛网膜下腔缓慢注射7.5 μg舒芬太尼能产生良好的镇痛效果,基本满足经产妇分娩镇痛的需求。国内WANG等[12]进行临床研究发现腰硬联合麻醉下使用舒芬太尼能够缩短总产程时间,产生镇痛效果所用时间明显短于硬膜外麻醉,与本研究结果基本一致。

另外,本研究结果显示,与对照组比较,5 μg舒芬太尼组缩短总产程时间、药物用量和不良反应发生率比较无统计学差异(均P > 0.05),表明5 μg舒芬太尼不能达到理想的镇痛效果,从而增加了罗哌卡因的用量。

本研究结果显示,3组新生儿的Apgar评分以及血气分析无统计学差异。POMA等[13]报道蛛网膜下腔注射舒芬太尼(3~5 μg)对子宫收缩影响小、起效更为迅速,并不会增加新生儿的并发症。赵岩等[14]研究蛛网膜下腔注射舒芬太尼和芬太尼效果比较时所用到的舒芬太尼剂量为7.5 μg,结果显示新生儿的Apgar评分未见异常。EVERAERT等[15]研究硬膜外和蛛网膜下腔注射舒芬太尼的差异,发现蛛网膜下腔注射舒芬太尼(7.5 μg)可能会引起胎儿胎心率的异常,但是在分娩和新生儿的结局上并无差异,与本研究结果基本一致。

综上所述,蛛网膜下腔注射7.5 μg舒芬太尼对经产妇分娩可起到快速的镇痛作用,并且能够减少其他药物的应用,缩短产程,不良反应发生率低,对产妇及新生儿影响小。本研究的不足之处:样本数量少,未进行胎儿胎心率监测与比较。今后要增加样本量,更加细化经产妇分组及观察指标,制定出最适合经产妇蛛网膜下腔注射舒芬太尼的分娩镇痛标准。

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