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RAVEL


Remifentanil patient controlled analgesia versus epidural analgesia during labour.

Go to the RAVEL trial website

Objective
This study considering cost effectiveness of remifentanil PCA  as first choice 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 labor if needed, 24 hours a day. According to LVR data (2008) 30% of pregnant women under care in a hospital need pain relief during labor.
A recent randomized study that compared RPCA with EA showed that in terms of pain scores (pain-intensity), EA is superior to that provided by RPCA. However, there was no difference in the pain relief scores (pain-appreciation) between the treatments.  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. In this study patients receiving PCA remifentanil will titrate themselves to an acceptable level of pain relief by pressing a button (and receiving an analgesic bolus dose).
It is expected that economical evaluation of both strategies will show a significant reduction in costs of this innovative strategy.
Other outcome measures are pain scores, patient satisfaction i.e. pain relief scores and validated questionnaires.

Study design
Randomized controlled multicentre trial

Study population
Women with a request for pain relief during labor between 32 and 42 weeks.

Inclusion criteria
Age >18 years
Labor between 32-42 weeks of gestation
ASA physical status I or II

Exclusion criteria
Prior administration of regional of opioid analgesia
Drug allergy: history of hypersensitivity to opioid or local anesthetic substances
Initial maternal SpO2 of less than 98%
Initial maternal temperature of 38C or higher
Contra-indication for epidural analgesia

Methods
Women will be randomized before actual labor starts to receive either remifentanil PCA of epidural analgesia should they request pain relief during labor.

Outcome measures
This study will assess in women with a request for pain relief during labour the cost-effectiveness of RPCA as first choice treatment compared to EA. We will look at the following outcomes: costs, pain relief scores (pain-appreciation), patient satisfaction, pain scores (pain-intensity), maternal and neonatal side effects.

Power/data analysis
The initial analysis will be performed by intention to treat. We hypothesize that there is no difference in pain relief scores with the two sided test (alfa=0.05, power 1-beta=0.9). In this non-inferiority design in each group 102 women have to be treated to exclude a potential clinical relevant difference of 10% (10 point scale, estimated SD 2.2). After correction for cross-over and non-compliance 568 patients are required. When only 50 percent of all women need actually treatment 1136 women have to be randomized.

Economic evaluation
The economic analysis will be performed from a short-term healthcare perspective. Anticipating on equality in pain relief scores the economic analysis will be a cost minimization analysis. For both strategies the cost of perinatal care for mother and child, starting at the onset of labor and ending ten days after delivery, will be registered and compared (without discounting).

Time schedule
36 months, including 27 months for inclusion (October 2010-April 2013)

Projectleaders
Dr JM Middeldorp, gynaecologist, LUMC
Dr KWM Bloemenkamp, gynaecologist, LUMC
Prof Dr A Dahan, anesthesiologist, LUMC

Health Technology Assessment
Dr ME van den Akker-van Marle, health economist, LUMC

Subsidy
ZonMW (
www.zonmw.nl)
Dossier number 80-82310-97-11039

Contact
Drs LM Freeman,  coordinator RAVEL trail
Dept. Obstetrics/ Gynaecology
LUMC (Leiden)
Tel: +31 (0)6 4545 4887
ravel@studies-obsgyn.nl