程控间断硬膜外注射与患者自控硬膜外镇痛维持分娩镇痛的比较：双中心双盲随机研究
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Programmed intermittent epidural bolus vs. patient-controlled epidural analgesia for maintenance of labour analgesia: a two-centre, double-blind, randomised study
背景与目的
与持续性硬膜外输注相比，程控间断硬膜外输注药物更具有优越性，无论是否设置患者自控硬膜外镇痛，都能减轻疼痛，减少运动阻滞并提高患者满意度。许多医疗机构仍在使用无背景输注剂量的患者自控硬膜外镇痛，但迄今为止，尚无任何研究进行程控间断硬膜外注射与无背景输注剂量的患者自控硬膜外镇痛之间的比较。
方 法
本项随机、双中心、双盲、对照试验，对程控间断硬膜外注射与无背景输注剂量的患者自控硬膜外镇痛这两种镇痛模式进行了评估。主要观察结果是需要麻醉医师追加剂量的剧烈疼痛的发生率。次要结果包括运动阻滞、疼痛评分、患者满意度、局麻药用量，以及产科和新生儿结局。
结 果
我们收集了130名首次接受硬膜外镇痛的待产妇，然后随机分配患者采用程控间断硬膜外注射或患者自控硬膜外镇痛的方式，使用0.12%罗哌卡因+0.75 µg·ml-1舒芬太尼启动并维持硬膜外镇痛。程控间断硬膜外注射组每小时程控10 ml，按需自控硬膜外注射5ml，锁定20min；患者自控硬膜外镇痛组每间隔12min锁定时间，硬膜外注射5ml。两组每小时潜在最大容积相同。与患者自控硬膜外镇痛组相比，程控间断硬膜外注射组的剧烈疼痛发生率较低[7 (10.9%) vs. 38 (62.3%; p < 0.0001)]。两组间运动阻滞频率（改良Bromage评分≤4）有显著差异[程控间断硬膜外注射组1 (1.6%) vs. 患者自控硬膜外镇痛组8 (13.1%); p = 0.015]。程控间断硬膜外注射组局麻药用量较大，患者自控硬膜外镇痛组用药量较少。两组之间的患者满意度评分、产科或新生儿结局无差异。
结 论
我们发现，10ml程控硬膜外注射+5ml自控硬膜外镇痛的程控间断硬膜外注射模式，优于自控剂量5ml的无背景输注剂量的患者自控硬膜外镇痛模式。
原始文献来源及摘要
Roofthooft E, Barbe A, Schildermans J, et al. Programmed intermittent epidural bolus vs. patient-controlled epidural analgesia for maintenance of labour analgesia: a two-centre, double-blind, randomised study.[J].Anaesthesia. 2020 Jun 12. doi: 10.1111/anae.15149.
Summary
The programmed intermittent epidural bolus technique has shown superiority to continuous epidural infusion techniques, with or without patient-controlled epidural analgesia for pain relief, reduced motor block and patient satisfaction. Many institutions still use patient-controlled epidural analgesia without a background infusion, and a comparative study between programmed intermittent epidural bolus and patient-controlled epidural analgesia without a background infusion has not yet been performed.
We performed a randomised, two-centre, double-blind, controlled trial of these two techniques. The primary outcome was the incidence of breakthrough pain requiring a top-up dose by an anaesthetist. Secondary outcomes included: motor block; pain scores; patient satisfaction; local anaesthetic consumption; and obstetric and neonatal outcomes.
We recruited 130 nulliparous women who received initial spinal analgesia, and then epidural analgesia was initiated and maintained with either programmed intermittent epidural bolus or patient-controlled epidural analgesia using ropivacaine 0.12% with sufentanil 0.75 µg·ml-1. The programmed intermittent epidural bolus group had a programmed bolus of 10 ml every hour, with on-demand patient-controlled epidural analgesia boluses of 5 ml with a 20 min lockout, and the patient-controlled epidural analgesia group had a 5 ml bolus with a 12 min lockout interval; the potential maximum volume per hour was the same in both groups. The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively. There was a significant difference in motor block (modified Bromage score ≤ 4) frequency between groups, programmed intermittent epidural bolus group 1 (1.6%) vs. patient-controlled epidural analgesia group 8 (13.1%); p = 0.015. The programmed intermittent epidural bolus group had greater local anaesthetic consumption with fewer patient-controlled epidural analgesia boluses. Patient satisfaction scores and obstetric or neonatal outcomes were not different between groups.
In conclusion, we found that a programmed intermittent epidural bolus technique using 10 ml programmed boluses and 5 ml patient-controlled epidural analgesia boluses was superior to a patient-controlled epidural analgesia technique using 5 ml boluses and no background infusion.
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贵州医科大学高鸿教授课题组
翻译：冯玉蓉 编辑：冯玉蓉 审校：曹莹