Abstract
BackgroundPain 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/designThe 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.DiscussionThis 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.Trial registration numberDutch Trial Register NTR2551, http://www.trialregister.nl
Highlights
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 during labour and is recommended as first method of pain relief by the Dutch Societies of Gynecologists and Anesthetists [1,2]
The objective of this study is to test the hypothesis that remifentanil patient controlled analgesia (PCA) is as effective as epidural analgesia with respect to patient satisfaction and pain appreciation scores, with lower costs and possibly the benefit of easier achievement of 24 hours availability of pain relief for women in labour
Summary
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. Its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. In the Netherlands its uptake by pregnant women in labour of all ethnicities is still limited (11.3% in 2008 but in the last years increasing with 1-2% per year), compared with other western countries, partly as a result of non-availability due to logistic problems. This is an undesirable situation, especially since the number of women asking for pain relief during labour is increasing. There is considerable variation in the availability of epidural analgesia within the UK as in the Netherlands [3]
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