Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands.
BMC Pregnancy Childbirth. 2012 Jul 2;12:63. doi: 10.1186/1471-2393-12-63.
Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments.
METHODS/DESIGN: The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia.Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief.Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects.The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared.
This study, considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia, could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly by giving them access to pain relief during labour, 24 hours a day.
Dutch Trial Register NTR2551, http://www.trialregister.nl.
分娩过程中的止痛是荷兰非常关注的话题。硬膜外镇痛被认为是最有效的止痛方法，并且被推荐作为首选。然而，与其他西方国家相比，孕妇对其的接受程度有限，部分原因是由于物流问题导致无法获得。瑞芬太尼是一种合成阿片类药物，非常适合患者自控镇痛。最近的研究表明，在疼痛强度评分方面，硬膜外镇痛优于瑞芬太尼患者自控镇痛; 然而，两种治疗方法在缓解疼痛的满意度方面没有差异。
方法/设计：本研究是一项多中心随机对照研究，评估瑞芬太尼患者自控镇痛与硬膜外镇痛的成本效益。我们假设瑞芬太尼患者自控镇痛在改善疼痛评估评分方面与硬膜外镇痛同样有效，并且具有更低的成本和更高的 24 小时可用性，以满足分娩妇女的止痛需求，同时也为那些有硬膜外镇痛禁忌症的妇女提供有效的止痛。符合条件的妇女将在活跃分娩开始前被告知研究并随机分组。当妇女在分娩过程中要求止痛时，将根据硬膜外镇痛或瑞芬太尼患者自控镇痛为她们分配策略。主要结局是疼痛评估评分，即对止痛的满意度。次要结局参数包括成本、患者满意度、疼痛评分（疼痛强度）、分娩方式以及母婴副作用。经济分析将从短期医疗保健角度进行。对于两种策略，将登记并比较从分娩开始到分娩后十天为止，母亲和儿童的围产期护理成本。
这项研究考虑了瑞芬太尼作为首选镇痛剂与硬膜外镇痛的成本效益，通过为荷兰每年约 18 万名分娩妇女提供 24 小时全天候的分娩止痛，可能会极大地改善她们的护理。
荷兰试验注册 NTR2551，http://www.trialregister.nl。
