Remifentanil patient controlled analgesia versus epidural analgesia during labor. The RAVEL-trial

Geplaatst op

Epidural analgesia (EA) is considered to be the most effective method of pain relief during labor and is recommended as first method of pain relief by the Dutch Societies of Gynecologists and Anesthetists. In the Netherlands its uptake by pregnant women in labor of all ethnicities is still limited (10%), compared with other western countries (40-80%), mainly 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 labor is increasing. Recently a new method of pain relief during labor, remifentanil patient controlled analgesia (RPCA) was introduced which seems effective in pain relief and safe. There was no difference in pain relief scores (pain appreciation) between EA and RPCA.
Since we know from other studies that equality in pain relief scores can be anticipated, this study will investigate patient satisfaction and costs as main outcome.
Study design: National non blinded multicenter randomized
controlled trial (RCT).

Study population: Pregnant women will be offered to participate in the study. Only women who have been informed before active labor has started, will be eligible. They will be randomized before active labor. They can participate when in labor between 32 and 42 weeks.
They will only receive analgesia during labor at their request. Inclusion of the study population has been finalized in 2012.

Intervention: women will be randomized to receive remifentanil patient controlled analgesia or epidural analgesia.

Primary objectives: cost effectiveness.

Secondary objectives: pain relief scores, patient satisfaction, pain scores, maternal and neonatal side effects

Doel

To assess in women with a request for pain relief during labor the cost-effectiveness of remifentanil patient controlled analgesia as first choice compared to epidural analgesia.

Vraagstelling/hypothese

We hypothesize that RPCA is as effective in reducing pain relief scores as EA, with lower costs and easier achievement of 24 hours availability of pain relief for women in labor.

Relevantie

This study considering cost effectiveness of RPCA as first choice versus EA could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly (according to LVR data (2008) 30% of pregnant women under care in a hospital need pain relief during labor), by giving them access to pain relief during labor if needed, 24 hours a day.

Begeleider(s)

Dr. J.M. Middeldorp, gynaecoloog, LUMC Leiden

Uitvoerder(s)

Drs. L.M. Freeman, LUMC Leiden

Partners

Het onderzoeksconsortium Verloskunde, Gynaecologie, Fertiliteit, Neonatologie, Gynaecologische Oncologie en Urogynaecologie

www.studies-obsgyn.nl

Contactpersonen

Drs. L.M. Freeman (LUMC Leiden)

Periode

Begindatum: januari 2011
Einddatum: januari 2014. Wacht nog op uitkomsten.



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