Drug design, development and therapy · 2026
0.06% Ropivacaine Combined with Double-Hole Dural Puncture Epidural Analgesia in Labor for Primiparous Women: A Prospective Randomized Controlled Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Piao Guangtian, Li Huiling, Jin Shengyu, Feng Lina, Zhao Yan, Jiang Meishuang, Zhou Tingting, Jin Meihua
Аннотация
BACKGROUND: Ultra-low concentration local anesthetics (ULCLA) preservation of labor progress is superior to low-concentration local anesthetics (LCLA), yet their analgesic efficacy remains suboptimal. While dural puncture epidural analgesia (DPEA) enhances traditional epidural (EP) efficacy, the clinical impact of the number of dural perforations during ULCLA maintenance remains unclarified.
OBJECTIVE: This study aims to evaluate the clinical efficacy and safety of 0.06% ropivacaine administered via programmed intermittent epidural bolus (PIEB) combined with double-perforation DPEA (D-DPEA) in primipara.
METHODS: 270 healthy primiparous women were randomized to EP (0.1% ropivacaine), single DPEA with 0.06% ropivacaine (S-DPEA) and double DPEA with 0.06% ropivacaine (D-DPEA). All received PIEB. The main outcome was the rate of breakthrough pain (pain requiring extra medication). Labor analgesia was maintained using the PIEB mode in all three groups. The primary outcome was the incidence of the breakthrough pain. Secondary outcomes included time to adequate analgesia, characteristics of sensory and motor blockade, labor progression, mode of delivery, and maternal-neonatal safety profiles.
RESULTS: A total of 224 primipara were included (EP group, n=74; S-DPEA group, n=74; D-DPEA group, n=76). The incidence of the breakthrough pain was significantly lower in D-DPEA group than in S-DPEA group (40.8% vs 77.0%, P < 0.001) and was comparable to that in the EP group (40.8% vs 45.9%, P = 0.524). Compared with S-DPEA, D-DPEA was associated with significantly faster analgesia onset and enhanced sacral block quality. Furthermore, compared with traditional EP, the D-DPEA group demonstrated reduced total anesthetic consumption, shorter labor durations, lower instrumental delivery rates, and a decreased incidence of maternal complications, such as hypotension and postpartum hemorrhage. Neonatal outcomes were similar among the groups.
CONCLUSION: The regimen of 0.06% ropivacaine combined with D-DPEA and PIEB is associated with improved obstetric outcomes compared with EP, and may mitigate the insufficient analgesia associated with ULCLA maintenance in S-DPEA.
OBJECTIVE: This study aims to evaluate the clinical efficacy and safety of 0.06% ropivacaine administered via programmed intermittent epidural bolus (PIEB) combined with double-perforation DPEA (D-DPEA) in primipara.
METHODS: 270 healthy primiparous women were randomized to EP (0.1% ropivacaine), single DPEA with 0.06% ropivacaine (S-DPEA) and double DPEA with 0.06% ropivacaine (D-DPEA). All received PIEB. The main outcome was the rate of breakthrough pain (pain requiring extra medication). Labor analgesia was maintained using the PIEB mode in all three groups. The primary outcome was the incidence of the breakthrough pain. Secondary outcomes included time to adequate analgesia, characteristics of sensory and motor blockade, labor progression, mode of delivery, and maternal-neonatal safety profiles.
RESULTS: A total of 224 primipara were included (EP group, n=74; S-DPEA group, n=74; D-DPEA group, n=76). The incidence of the breakthrough pain was significantly lower in D-DPEA group than in S-DPEA group (40.8% vs 77.0%, P < 0.001) and was comparable to that in the EP group (40.8% vs 45.9%, P = 0.524). Compared with S-DPEA, D-DPEA was associated with significantly faster analgesia onset and enhanced sacral block quality. Furthermore, compared with traditional EP, the D-DPEA group demonstrated reduced total anesthetic consumption, shorter labor durations, lower instrumental delivery rates, and a decreased incidence of maternal complications, such as hypotension and postpartum hemorrhage. Neonatal outcomes were similar among the groups.
CONCLUSION: The regimen of 0.06% ropivacaine combined with D-DPEA and PIEB is associated with improved obstetric outcomes compared with EP, and may mitigate the insufficient analgesia associated with ULCLA maintenance in S-DPEA.