Effect of dural puncture epidural technique combined with programmed intermittent epidural bolus on labor analgesia: A randomized, double-blind, parallel-group, controlled clinical trial

硬膜穿刺硬膜外麻醉联合程序性间歇硬膜外推注对分娩镇痛效果的影响:一项随机、双盲、平行组、对照临床试验

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Abstract

BACKGROUND: Labor analgesia can be achieved by different approaches. The efficacy and safety of combined dural puncture epidural (DPE) with program intermittent epidural bolus (PIEB) are not well characterized. This study aimed to compare the efficacy and safety of DPE combined with PIEB vs epidural (EP) combined with PIEB for labor analgesia. METHODS: We performed a prospective, randomized, double-blind, parallel-group, controlled clinical trial. Eligible pregnant nulliparous women received either DPE combined with PIEB (group D) or epidural combined with PIEB (group E) for labor analgesia. Analgesia was initiated with 0.1% ropivacaine + 0.3 µg/mL sufentanil and maintained with PIEB at 12 mL/h. Primary outcome was the proportion of women with adequate analgesia within 10 minutes after the initiation of analgesics. Secondary outcomes (time to achieve analgesia, time to first request for additional analgesic, proportion of women required additional analgesic or epidural catheter adjustment and resetting, total labor duration, total analgesic consumption, level of anesthesia, and motor block), side effects, and patient satisfaction were also documented. RESULTS: Out of 174 enrolled women, 160 were included in the analysis. Baseline characteristics were comparable. The proportion of women who achieved adequate analgesia in group D was significantly greater than that in group E (38.8% vs 20.0%, P < .05). Compared with group E, group D also showed advantages in faster adequate analgesic achievement, more likely to reach adequate analgesia, a longer time to maintain analgesia, lesser requirements for additional analgesic, and better sensory blocks. There were no significant inter-group differences in other outcome measures. CONCLUSIONS: Compared with epidural and PIEB mode, DPE and PIEB mode achieved better analgesia without increasing maternal or neonatal side-effects during labor.

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