title: Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Dutch Trial Register NTR2551, http://www.trialregister.nl.
authors: Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands. l.m.freeman@lumc.nl
authors: Liv M
authors: LM
authors: Freeman
authors: Kitty W M
authors: KW
authors: Bloemenkamp
authors: Maureen T M
authors: MT
authors: Franssen
authors: Dimitri N M
authors: DN
authors: Papatsonis
authors: Petra J
authors: PJ
authors: Hajenius
authors: Marloes E
authors: ME
authors: van Huizen
authors: Henk A
authors: HA
authors: Bremer
authors: Eline S A
authors: ES
authors: van den Akker
authors: Mallory D
authors: MD
authors: Woiski
authors: Martina M
authors: MM
authors: Porath
authors: Erik
authors: E
authors: van Beek
authors: Nico
authors: N
authors: Schuitemaker
authors: Paulien C M
authors: PC
authors: van der Salm
authors: Bianca F
authors: BF
authors: Fong
authors: Celine
authors: C
authors: Radder
authors: Caroline J
authors: CJ
authors: Bax
authors: Marko
authors: M
authors: Sikkema
authors: M Elske
authors: ME
authors: van den Akker-van Marle
authors: Jan M M
authors: JM
authors: van Lith
authors: Enrico
authors: E
authors: Lopriore
authors: Renske J
authors: RJ
authors: Uildriks
authors: Michel M R F
authors: MM
authors: Struys
authors: Ben Willem J
authors: BW
authors: Mol
authors: Albert
authors: A
authors: Dahan
authors: Johanna M
authors: JM
authors: Middeldorp
mesh_terms: D000293:Adolescent; D000328:Adult; D015360:Analgesia, Epidural / Q000009:adverse effects / Q000191:economics; D016362:Analgesia, Obstetrical / Q000009:adverse effects / Q000379:methods*; D016058:Analgesia, Patient-Controlled / Q000009:adverse effects / Q000191:economics; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007743:Labor, Obstetric; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D017060:Patient Satisfaction / Q000191:economics; D010880:Piperidines / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D011247:Pregnancy; D000077208:Remifentanil; D012107:Research Design; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D010880:Piperidines; D000077208:Remifentanil