| Objective: To investigate the safety and effects of the dural puncture epidural(DPE)combined with programmed intermittent epidural boluses(PIEB)technique for labor analgesia,delivery process,delivery outcome,adverse reactions and maternal satisfaction,and to comprehensively evaluate the safety and efficacy of DPE combined with PIEB technology for labor analgesia.Methods : This study is a prospective,double-blind,randomized controlled trial.A block randomization method was used to randomly divide 180 healthy nulliparous women who were to undergo labor analgesia into a conventional epidural block combined with PIEB group(EPL group),and a combined spinalepidural anesthesia combined with PIEB group(CSE group),DPE combined with PIEB group(DEP group),60 cases in each group.After successful epidural puncture,the EPL group was routinely placed with an epidural catheter;in the CSE group,a 25 G lumbar puncture needle was used to puncture the dural,and analgesics(ropivacaine 2.5 mg + sufentanil 2.5 μg)were injected into the subarachnoid space,after the lumbar puncture needle was withdrawn,an epidural catheter was placed cephalad;in the DEP group,the dural was punctured with a25 G spinal anesthesia needle but no spinal anesthesia drug was given,and then the epidural catheter was placed.The initial epidural loading dose for analgesia in the EPL and DEP groups was 0.15% ropivacaine + 0.4 μg/ml sufentanil 10-15 ml,and the target plane was T10.The three groups of maternal analgesia were maintained by PIEB technology.The analgesic drug was 0.075% ropivacaine +0.4 μg/ml sufentanil mixture.The parameters were set as: pulse dose is 10 ml/time,pulse interval is 1 h,PCEA dose is 5 ml/time,and the locking time is 20 min.The main research indicators were the time to adequate analgesia and the incidence of the breakthrough pain,the secondary indicators included the visual analog scale(VAS)before labor analgesia(T0)、10 minutes(T1)、 20 minutes(T2)、30 minutes(T3)、60 min(T4)、120 min(T5)、full cervix(T6)and fetal delivery(T7)after epidural administration,PCEA and artificial rescue analgesia times,consumption of ropivacaine per hour,the incidence of sacrocaudal block insufficiency,maternal satisfaction score,and adverse effects during labor analgesia(deceleration of fetal heart rate,maternal hypotension,pruritus,fever,nausea and vomiting,motor block,headache after epidural puncture,etc.)and delivery outcome indicators(first stage of labor,second stage of labor,neonatal Apgar score at 1 min and 5 min,and the mode of delivery,etc.).Results: A total of 178 puerperae(59 in the EPL group,60 in the CSE group,and 59 in the DPE group)completed and were finally included in the trial.There was no significant difference in the general data of the three groups of puerperae(P>0.05).Comparing the time to adequate analgesia among the three groups,the DPE group and the CSE group were significantly faster than the EPL group,while the CSE group was significantly faster than the DPE group,and the difference was statistically significant(P<0.0167).Compared with the three groups,the incidence rate of maternal breakout pain in DPE group and CSE group was significantly lower than that in EPL group(P<0.0167),but there was no significant difference between DPE group and CSE group(P>0.0167).Compared with the EPL group,the PCEA rate,the incidence of rescue analgesia,the incidence of sacrocaudal block insufficiency and the hourly consumption of ropivacaine in the CSE group and DPE group were significantly lower(P<0.0167).Comparison of VAS scores at each time point in the delivery process of the three groups: At T1 time point,compared with the EPL group,the VAS scores of the DPE group and the CSE group were significantly lower(P < 0.0167),and compared with the CSE group,the VAS score of the DPE group was significantly lower than that of the CSE group.At T2 time point,the VAS score of the CSE group was significantly lower than that of the EPL group(P<0.0167),but there was no significant difference between the DPE group and the EPL group、the DPE group and the CSE group(P>0.0167);There was no significant difference in the VAS scores among the three groups at other time points(P>0.05).Compared with the CSE group,the incidence of pruritus in the EPL group and DPE group was significantly lower(P<0.0167).There was no significant difference among the three groups in the incidence of adverse reactions such as motor block,nausea and vomiting,fetal heart rate deceleration,hypotension,fever,headache after puncture(P>0.05).There were no significant differences in the first stage of labor,second stage of labor,mode of delivery,and Apgar scores of newborns at 1 min and 5 min among the three groups(P>0.05).There were no significant difference in maternal satisfaction between three groups(P>0.0167).Conclusions: DPE combined with PIEB technology has a faster analgesic effect than traditional EPL technology,a lower incidence of breakthrough pain,a lower PCEA rate and rescue analgesia rate,a lower incidence of sacrocaudal block insufficiency and a lower hourly consumption of ropivacaine.The incidence of pruritus in DPE is lower than CSE,and it does not increase other adverse reactions,and does not affect the labor process or delivery outcome.It can be safely and effectively used for labor analgesia. |
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