医学
外科
麻醉
临床试验
腰硬联合麻醉
临床疗效
硬膜穿刺后头痛
梅德林
随机对照试验
校长(计算机安全)
作者
Yu Zang,Weijia Du,Xiaobing Hu,Xin Fang,Wei Luo,Zhendong Xu
标识
DOI:10.1097/eja.0000000000002330
摘要
BACKGROUND: No relevant clinical studies have investigated how epidural catheter design influences the transmeningeal flux of drugs. OBJECTIVE: To compare the analgesic outcomes between single-orifice and multiorifice wire-reinforced catheters following dural puncture epidural (DPE) for labour analgesia. DESIGN: Prospective double-blind randomised controlled study. SETTING: Shanghai First Maternity and Infant Hospital. PATIENTS: Between 1 September and 27 October 2024 healthy, nulliparous women with singleton pregnancies, cervical dilation of 2 to 5 cm, and requesting neuraxial analgesia were randomised to receive either a single-orifice or multiple-orifice polyurethane wire-reinforced epidural catheter as as part of the DPE technique along with a 25-G spinal needle. INTERVENTION: Epidural analgesia was initiated following DPE with 12 ml of 0.1% ropivacaine and 0.3 μg ml -1 sufentanil injected manually in two divided doses of 6 ml. Maintenance was then provided via programmed intermittent epidural boluses of the same solution, delivered as 10 ml every 40 min at an infusion rate of 360 ml h -1 . MAIN OUTCOME MEASURES: The primary endpoint was the time required to achieve a numeric rating scale pain score 3 or less following the initial bolus. RESULTS: Of 136 randomised participants, 131 were included in the analysis. Adequate analgesia was achieved significantly faster with single-orifice catheters than with multiorifice catheters, hazard ratio (HR) and 95% confidence intervals (CI) = 1.72 (1.17 to 2.53), P = 0.003. Post hoc sensitivity analysis confirmed these results, HR = 1.79 (1.19 to 2.71), P = 0.005.The median time (95% CI) to adequate analgesia was 11.0 (10.0 to 13.0) min for single-orifice and 14.0 (12.0 to 18.0) min for multiorifice catheters ( P = 0.003). The single-orifice group demonstrated higher rates of adequate analgesia (89.2 vs. 72.7%, P = 0.02) and bilateral S2 sensory blockade (95.4 vs. 83.3%, P = 0.03) at 20 min, with no significant differences in other parameters. CONCLUSIONS: DPE using a 25-G spinal needle and with a single-orifice catheter produced a significantly faster onset of analgesia than DPE with a multiorifice catheter during labour initiation. TRIAL REGISTRATION: Chinese Clinical Trial Registry (No: ChiCTR2400088640; Principal investigator: Yu Zang; Registration date: 22 August 2024).
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