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Open Access Highly Accessed Study protocol

Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

Liv M Freeman1*, Kitty WM Bloemenkamp1, Maureen TM Franssen2, Dimitri NM Papatsonis3, Petra J Hajenius4, Marloes E van Huizen5, Henk A Bremer6, Eline SA van den Akker7, Mallory D Woiski8, Martina M Porath9, Erik van Beek10, Nico Schuitemaker11, Paulien CM van der Salm12, Bianca F Fong13, Celine Radder14, Caroline J Bax15, Marko Sikkema16, M Elske van den Akker-van Marle17, Jan MM van Lith1, Enrico Lopriore18, Renske J Uildriks19, Michel MRF Struys19, Ben Willem J Mol4, Albert Dahan20 and Johanna M Middeldorp1

Author Affiliations

1 Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands

2 Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, the Netherlands

3 Department of Obstetrics and Gynaecology, Amphia hospital, Breda, the Netherlands

4 Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, the Netherlands

5 Department of Obstetrics and Gynaecology, HagaZiekenhuis, Den Haag, the Netherlands

6 Department of Obstetrics and Gynaecology, Reinier de Graaf Gasthuis, Delft, the Netherlands

7 Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands

8 Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

9 Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, the Netherlands

10 Department of Obstetrics and Gynaecology, St. Antonius hospital, Nieuwegein, the Netherlands

11 Department of Obstetrics and Gynaecology, Diakonessenhuis, Utrecht, the Netherlands

12 Department of Obstetrics and Gynaecology, Meander Medical Centre, Amersfoort, the Netherlands

13 Department of Obstetrics and Gynaecology, Zaans Medical Centre, Zaandam, the Netherlands

14 Department of Obstetrics and Gynaecology, St Lucas Andreas hospital, Amsterdam, the Netherlands

15 Department of Obstetrics and Gynaecology, VU Medical Centre, Amsterdam, the Netherlands

16 Department of Obstetrics and Gynaecology, ZiekenhuisGroepTwente, Almelo, the Netherlands

17 Department of Medical Decision Making, Leiden University Medical Centre, Leiden, the Netherlands

18 Department of Pediatrics, Leiden University Medical Centre, Leiden, the Netherlands

19 Department of Anesthesiology, University Medical Centre Groningen, Groningen, the Netherlands

20 Department of Anesthesiology, Leiden University Medical Centre, Leiden, the Netherlands

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BMC Pregnancy and Childbirth 2012, 12:63  doi:10.1186/1471-2393-12-63

Published: 2 July 2012

Abstract

Background

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.

Discussion

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.

Trial registration number

Dutch Trial Register NTR2551, http://www.trialregister.nl webcite

Keywords:
Analgesia; Labour; Remifentanil; Patient controlled analgesia; Epidural