European journal of anaesthesiology · 2025
Comparison of analgesia efficacy between single-orifice and multiorifice wire-reinforced catheters for labour analgesia with the dural puncture epidural technique: A double-blind randomised controlled trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Zang Yu, Du Weijia, Hu Xiaobing, Fang Xin, Luo Wei, Xu Zhendong
Аннотация
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).
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).