单纯罗哌卡因与罗哌卡因复合舒芬太尼在硬膜外分娩镇痛中的比较

目的比较单纯罗哌卡因与罗哌卡因复合舒芬太尼在硬膜外分娩镇痛中的有效性和安全性。方法选择要求硬膜外分娩镇痛的产妇481例,年龄18~45岁,ASAⅠ级,随机分为两组,硬膜外分别给予0.125%罗哌卡因(R组,n=241)或0.125%罗哌卡因复合0.3μg/ml舒芬太尼(RS组,n=240)。记录产程中NRS疼痛评分及VAS镇痛满意度评分,产妇Bromage运动评分及不良反应情况,以及新生儿Apgar评分及脐带血气分析。结果最终纳入产妇346例,R组164例,RS组182例。第一产程NRS评分RS组2.2分(IQR 1.8~2.7分),明显低于R组2.4分(IQR 2~2.8分)(P0.001),第二产程两组NRS评分差异无统计学意义。两组VAS镇痛满意度差异无统计学意义。分娩镇痛相关不良反应发生率RS组47.2%,R组37.7%,两组差异无统计学意义。RS组1 min的Apgar评分≤7分的比例为5.5%,明显高于R组1.2%(P0.05)。结论单纯罗哌卡因用于硬膜外分娩镇痛与罗哌卡因复合舒芬太尼效果相似,但产妇不良反应更少,新生儿1 min的Apgar评分≤7分的比例更低。

Comparison of the efficacy and safety between the use of ropivacaine alone and ropivacaine with sufentanil in epidural labor analgesia

Objective To compare the analgesic efficacy and safety of the sole local anesthetic ropivacaine with the combination of both local anesthetic ropivacaine and opioidergic analgesic sufen-tanil given epidurally on the labor pain control.Methods After institutional review board approval and patient consent,a total of 481 nulliparas requesting epidural labor analgesia were randomized into two groups:a sole local anesthetic group (0.125% ropivacaine,group R)and a combination of local anesthetic and opioidergic analgesic group (0.125% ropivacaine+0.3 μg/ml sufentanil,group RS). Analgesic efficacy was measured using numerical rating scale (NRS)of pain and maternal visual ana-logue scale (VAS)analgesia satisfaction with regard to the first and the second stage of labor.Anal-gesic safety was measured with the Bromage scale of maternal safety and epidural labor analgesia re-lated side effects,as well as fetal safety including Apgar scoring and umbilical cord artery blood gas a-nalysis.Results A total of 346 participants completed the study,with 1 64 and 182 women in each group R and RS,respectively.The median NRS pain score during the first stage of labor was signifi-cantly lower in the combination group (2.2,IQR:1.8-2.7 )comparing to the sole local analgesic group (2.4,IQR:2-2.8)(P <0.001).No significant difference was observed in NRS pain score dur-ing the second stage of labor.Patients in both groups were rated the same VAS satisfaction of analge-sia.Patients in the sole local analgesic group experienced fewer side effects than those in the combina-tion group (37.7% versus 47.2%,P =0.082).The incidence of 1-min Apgar≤7 was lower in the sole local analgesic group 2 (1.2%) than the combination group 10 (5.5%) (P < 0.05 ). Conclusion The sole local anesthetic ropivacaine produces a comparable labor analgesic effect as the combination of both local anesthetic ropivacaine and opioidergic analgesic sufentanil but the former has less maternal side effects,and less incidence of lower 1-min Apgar scoring.