Shen XiaoFeng, Li Yunping, Xu ShiQin, Wang Nan, Fan Sheng, Qin Xiang, Zhou Chunxiu, Hess Philip E
Departments of Anesthesiology and Obstetrics and Gynecology, Nanjing Maternity and Child Health Care Hospital, Nanjing Medical University, Nanjing, Jiangsu, China; and the Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Obstet Gynecol. 2017 Nov;130(5):1097-1103. doi: 10.1097/AOG.0000000000002306.
To evaluate whether maintaining a motor-sparing epidural analgesia infusion affects the duration of the second stage of labor in nulliparous parturients compared with a placebo control.
We conducted a double-blind, randomized, placebo-controlled trial involving nulliparous women with term cephalic singleton pregnancies who requested epidural analgesia. All women received epidural analgesia for the first stage of labor using 0.08% ropivacaine with 0.4 micrograms/mL sufentanil with patient-controlled epidural analgesia. At the onset of the second stage of labor, women were randomized to receive a blinded infusion of the same solution or placebo saline infusion. The primary outcome was the duration of the second stage of labor. A sample size of 200 per group (400 total) was planned to identify at least a 15% difference in duration.
Between March 2015 and September 2015, 560 patients were screened and 400 patients (200 in each group) completed the study. Using an intention-to-treat analysis, the duration of the second stage was similar between groups (epidural 52±27 minutes compared with saline 51±25 minutes, P=.52). The spontaneous vaginal delivery rate was also similar (epidural 193 [96.5%] compared with saline 198 [99%], P=.17). Pain scores were similar between groups at each measurement during the second stage. More women who received placebo reported satisfaction scores of 8 or less (epidural 32 [16%] compared with saline 61 [30.5%], P=.001).
Maintaining the infusion of epidural medication had no effect on the duration of the second stage of labor compared with a placebo infusion. Maternal and neonatal outcomes were similar. A low concentration of epidural local anesthetic does not affect the duration of the second stage of labor.
Chinese Clinical Trial Register, http://www.chictr.org.cn/enindex.aspx, ChiCTR-IOR-15005875.
与安慰剂对照相比，评估维持保留运动功能的硬膜外镇痛输注是否会影响初产妇第二产程的时长。
我们进行了一项双盲、随机、安慰剂对照试验，纳入了要求硬膜外镇痛的足月头位单胎初产妇。所有产妇在第一产程均使用0.08%罗哌卡因与0.4微克/毫升舒芬太尼进行患者自控硬膜外镇痛。在第二产程开始时，产妇被随机分组，接受相同溶液的盲法输注或安慰剂生理盐水输注。主要结局是第二产程的时长。计划每组样本量为200例（共400例），以确定时长上至少15%的差异。
2015年3月至2015年9月期间，筛查了560例患者，400例患者（每组200例）完成了研究。采用意向性分析，两组间第二产程时长相似（硬膜外组52±27分钟，生理盐水组51±25分钟，P = 0.52）。自然阴道分娩率也相似（硬膜外组193例[96.5%]，生理盐水组198例[99%]，P = 0.17）。第二产程各测量时点两组间疼痛评分相似。更多接受安慰剂的产妇报告满意度评分在8分及以下（硬膜外组32例[16%]，生理盐水组61例[30.5%]，P = 0.001）。
与安慰剂输注相比，维持硬膜外药物输注对第二产程时长无影响。母婴结局相似。低浓度硬膜外局部麻醉药不影响第二产程时长。
中国临床试验注册中心，http://www.chictr.org.cn/enindex.aspx，ChiCTR-IOR-15005875 。
