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Comparison of analgesia efficacy between single-orifice and multiorifice wire-reinforced catheters for labour analgesia with the dural puncture epidural technique

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
出处
期刊:European Journal of Anaesthesiology [Lippincott Williams & Wilkins]
卷期号:43 (7): 575-583
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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