Department of Anaesthesiology, GZA Sint Augustinus Hospital, Antwerp, Belgium.
Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.
Anaesthesia. 2023 Sep;78(9):1129-1138. doi: 10.1111/anae.16060. Epub 2023 Jun 20.
The aim of neuraxial analgesia is to achieve excellent pain relief with the fewest adverse effects. The most recently introduced technique for epidural analgesia maintenance is the programmed intermittent epidural bolus. In a recent study, we compared this with patient-controlled epidural analgesia without a background infusion and found that a programmed intermittent epidural bolus was associated with less breakthrough pain, lower pain scores, higher local anaesthetic consumption and comparable motor block. However, we had compared 10 ml programmed intermittent epidural boluses with 5 ml patient-controlled epidural analgesia boluses. To overcome this potential limitation, we designed a randomised, multicentre non-inferiority trial using 10 ml boluses in each group. The primary outcome was the incidence of breakthrough pain and total analgesic intake. Secondary outcomes included motor block; pain scores; patient satisfaction; and obstetric and neonatal outcomes. The trial was considered positive if two endpoints were met: non-inferiority of patient-controlled epidural analgesia with respect to breakthrough pain; and superiority of patient-controlled epidural analgesia with respect to local anaesthetic consumption. A total of 360 nulliparous women were allocated randomly to patient-controlled epidural analgesia-only or programmed intermittent epidural bolus groups. The patient-controlled group received 10 ml boluses of ropivacaine 0.12% with sufentanil 0.75 μg.ml ; the programmed intermittent group received 10 ml boluses supplemented by 5 ml patient-controlled boluses. The lockout period was 30 min in each group and the maximum allowed hourly local anaesthetic/opioid consumption was identical between the groups. Breakthrough pain was similar between groups (11.2% patient controlled vs. 10.8% programmed intermittent, p = 0.003 for non-inferiority). Total ropivacaine consumption was lower in the PCEA-group (mean difference 15.3 mg, p < 0.001). Motor block, patient satisfaction scores and maternal and neonatal outcomes were similar across both groups. In conclusion, patient-controlled epidural analgesia is non-inferior to programmed intermittent epidural bolus if equal volumes of patient-controlled epidural analgesia are used to maintain labour analgesia and superior with respect to local anaesthetic consumption.
椎管内镇痛的目的是在达到最佳的镇痛效果的同时产生最少的不良反应。最近引入的硬膜外镇痛维持技术是程控间歇硬膜外推注。在最近的一项研究中，我们将其与无背景输注的患者自控硬膜外镇痛进行了比较，发现程控间歇硬膜外推注与较少的爆发性疼痛、较低的疼痛评分、更高的局部麻醉药消耗和相当的运动阻滞相关。然而，我们曾将 10ml 程控间歇硬膜外推注与 5ml 患者自控硬膜外镇痛推注进行比较。为了克服这一潜在的局限性，我们设计了一项随机、多中心非劣效性试验，每组使用 10ml 推注。主要结局是爆发性疼痛的发生率和总镇痛剂用量。次要结局包括运动阻滞、疼痛评分、患者满意度以及产科和新生儿结局。如果满足以下两个终点，试验被认为是阳性的：与爆发性疼痛相比，患者自控硬膜外镇痛具有非劣效性；与局部麻醉药消耗相比，患者自控硬膜外镇痛具有优越性。共纳入 360 名初产妇随机分配至患者自控硬膜外镇痛组或程控间歇硬膜外推注组。患者自控组接受罗哌卡因 0.12%和舒芬太尼 0.75μg/ml 的 10ml 推注；程控间歇组接受 10ml 推注，并补充 5ml 患者自控推注。每组的锁定时间为 30 分钟，两组允许的每小时最大局部麻醉药/阿片类药物消耗相同。两组之间的爆发性疼痛相似（患者自控组 11.2%，程控间歇组 10.8%，非劣效性 p=0.003）。PCEA 组罗哌卡因总消耗量较低（平均差异 15.3mg，p<0.001）。运动阻滞、患者满意度评分以及母婴结局在两组间相似。总之，如果使用等量的患者自控硬膜外镇痛来维持分娩镇痛，患者自控硬膜外镇痛与程控间歇硬膜外推注相比非劣效，而在局部麻醉药消耗方面具有优越性。
