Department of Anaesthesiology, Arnaud de Villeneuve University Hospital, Montpellier, France.
Clinical Research and Epidemiology Unit, Medical Information Department, Montpellier University Hospital, Montpellier, France.
Anaesthesia. 2016 May;71(5):535-43. doi: 10.1111/anae.13406. Epub 2016 Mar 2.
We assessed the effectiveness of early patient-controlled oral analgesia compared with parenteral analgesia in a randomised controlled non-inferiority trial of women undergoing elective caesarean section under regional anaesthesia. Seventy-seven women received multimodal paracetamol, ketoprofen and morphine analgesia. The woman having patient-controlled oral analgesia were administered four pillboxes on the postnatal ward containing tablets and instructions for self-medication, the first at 7 h after the spinal injection and then three more at 12-hourly intervals. Pain at rest and on movement was evaluated using an 11-point verbal rating scale at 2 h and then at 6-hourly intervals for 48 h. The pre-defined non-inferiority limit for the difference in mean pain scores (patient-controlled oral analgesia minus parenteral) was one. The one-sided 95% CI of the difference in mean pain scores was significantly lower than one at all time-points at rest and on movement, demonstrating non-inferiority of patient-controlled oral analgesia. More women used morphine in the patient-controlled oral analgesia group (22 (58%)) than in the parenteral group (9 (23%); p = 0.002). The median (IQR [range]) number of morphine doses in the patient-controlled oral analgesia group was 2 (1-3 [1-7]) compared with 1 (1-1 [1-2]); p = 0.006) in the parenteral group. Minor drug errors or omissions were identified in five (13%) women receiving patient-controlled oral analgesia. Pruritus was more frequent in the patient-controlled oral analgesia group (14 (37%) vs 6 (15%) respectively; p = 0.03), but no differences were noted for other adverse events and maternal satisfaction. After elective caesarean section, early patient-controlled oral analgesia is non-inferior to standard parenteral analgesia for pain management, and can be one of the steps of an enhanced recovery process.
我们在一项针对接受区域麻醉下择期剖宫产的女性的随机对照非劣效性试验中评估了早期患者自控口服镇痛与患者自控静脉镇痛的效果。77 名女性接受了多模式扑热息痛、酮咯酸和吗啡镇痛。接受患者自控口服镇痛的女性在产后病房接受了四盒药丸和自我用药说明,第一盒在椎管内注射后 7 小时服用,然后每 12 小时服用一次。在 2 小时和随后的 6 小时间隔内,使用 11 点言语评分量表评估静息和运动时的疼痛。平均疼痛评分(患者自控口服镇痛减去患者自控静脉镇痛)的差异的预先确定非劣效性限值为 1。在静息和运动时的所有时间点,差异的单侧 95%CI 均显著低于 1,表明患者自控口服镇痛具有非劣效性。在患者自控口服镇痛组(22 [58%])中使用吗啡的女性多于患者自控静脉镇痛组(9 [23%];p = 0.002)。患者自控口服镇痛组的吗啡剂量中位数(IQR[范围])为 2(1-3[1-7]),而患者自控静脉镇痛组为 1(1-1[1-2]);p = 0.006)。在接受患者自控口服镇痛的女性中,有 5 名(13%)发现药物错误或遗漏。在患者自控口服镇痛组中,瘙痒更为常见(14 [37%] vs 6 [15%];p = 0.03),但其他不良事件和产妇满意度无差异。在择期剖宫产术后,早期患者自控口服镇痛在疼痛管理方面不劣于标准患者自控静脉镇痛,并且可以作为加速康复流程的步骤之一。