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程控间歇性硬膜外单次推注分娩镇痛:125ml/h 与 250ml/h 推注速度的随机对照试验。

Programmed intermittent epidural bolus for labour analgesia: a randomized controlled trial comparing bolus delivery speeds of 125 mL·hr versus 250 mL·hr.

机构信息

Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, 600 University Avenue, Room 7-405, Toronto, ON, M5G 1X5, Canada.

Department of Pediatrics, Micare Research Centre, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.

出版信息

Can J Anaesth. 2022 Jan;69(1):86-96. doi: 10.1007/s12630-021-02132-w. Epub 2021 Nov 1.

Abstract

PURPOSE

Programmed intermittent epidural bolus (PIEB) provides better analgesia for labour pain than continuous epidural infusion does. Nevertheless, commonly used PIEB regimens are associated with high sensory block. We hypothesized that a PIEB technique with slower bolus delivery speed would produce lower sensory levels.

METHODS

We recruited term nulliparous women with singleton pregnancies during the first stage of labour. All participants had an American Society of Anesthesiologists Physical Status score of II-III, had epidural catheters placed at L3/4, and had epidural analgesia maintained with PIEB 10 mL every 40 min using 0.0625% bupivacaine with fentanyl 2 µg·mL. Women were randomized to receive PIEB delivered at 250 mL·hr (G250) or 125 mL·hr (G125). The study was completed six hours after the loading dose or at full cervical dilatation, whichever occurred first. The primary outcome was the presence of sensory block to ice ≥ T6 in at least one assessment during the study period (maximum six hours).

RESULTS

We analyzed data from 90 women. The proportion of women presenting sensory block ≥ T6 at any time was not different between G125 and G250 groups (60.0% vs 64.4%; difference, -4.4%; 95% confidence interval [CI], -24.5 to 15.6; P = 0.66). The median [interquartile range] highest sensory block level was also not different between G125 and G250 groups (T6 [T7-T5] vs T5 [T7-T5], P = 0.39). Women in the G125 group had a lower incidence of hypotension than women in the G250 group did (11.1% vs 33.3%; difference, -22.2%; 95% CI, -38.8 to -5.67; P = 0.01). Quality of analgesia and patient satisfaction were not different between groups.

CONCLUSION

The maintenance of epidural analgesia with a PIEB delivery speed of 125 mL·hr did not produce lower sensory block levels when compared with 250 mL·hr. The slower injection speed regimen was associated with lower incidence of hypotension, but this secondary finding warrants confirmation in a future trial.

TRIAL REGISTRATION

www.ClinicalTrials.gov (NCT03236298); registered 1 August 2017.

摘要

目的

与持续硬膜外输注相比,程控间歇性硬膜外推注(PIEB)可为分娩疼痛提供更好的镇痛效果。然而,常用的 PIEB 方案与较高的感觉阻滞相关。我们假设,使用较慢的推注速度的 PIEB 技术将产生较低的感觉水平。

方法

我们招募了处于第一产程的足月初产妇。所有参与者的美国麻醉医师协会身体状况评分为 II-III 级,在 L3/4 处放置硬膜外导管,并使用 0.0625%布比卡因和 2µg·mL 的芬太尼进行 PIEB 10 mL 每 40 分钟一次的硬膜外镇痛。将女性随机分为以 250 mL·hr(G250)或 125 mL·hr(G125)的速度输注 PIEB。研究在负荷剂量后 6 小时或宫颈完全扩张时完成,以先发生者为准。主要结局是在研究期间的至少一次评估中存在对冰的感觉阻滞≥T6(最长 6 小时)。

结果

我们分析了 90 名女性的数据。在任何时候出现感觉阻滞≥T6 的女性比例在 G125 和 G250 组之间没有差异(60.0%与 64.4%;差异,-4.4%;95%置信区间[CI],-24.5 至 15.6;P=0.66)。G125 和 G250 组的最高感觉阻滞水平中位数[四分位距]也无差异(T6[T7-T5]与 T5[T7-T5],P=0.39)。与 G250 组相比,G125 组的低血压发生率较低(11.1%与 33.3%;差异,-22.2%;95%CI,-38.8 至-5.67;P=0.01)。两组的镇痛质量和患者满意度无差异。

结论

与 250 mL·hr 相比,以 125 mL·hr 的 PIEB 输送速度维持硬膜外镇痛并未产生较低的感觉阻滞水平。较慢的注射速度方案与低血压发生率降低相关,但这一次要发现需要在未来的试验中证实。

试验注册

www.ClinicalTrials.gov(NCT03236298);2017 年 8 月 1 日注册。

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