• Liv M Freeman, Kitty W Bloemenkamp, Maureen T Franssen, Dimitri N Papatsonis, Petra J Hajenius, Markus W Hollmann, Mallory D Woiski, Martina Porath, Hans J van den Berg, Erik van Beek, Odette W H M Borchert, Nico Schuitemaker, J Marko Sikkema, A H M Kuipers, Sabine L M Logtenberg, Paulien C M van der Salm, Katrien Oude Rengerink, Enrico Lopriore, M Elske van den Akker-van Marle, Saskia le Cessie, Jan M van Lith, Michel M Struys, Ben Willem J Mol, Albert Dahan, and Johanna M Middeldorp.
• Obstetrics, Leiden University Medical Centre, Leiden, Netherlands l.m.freeman@lumc.nl.
• BMJ. 2015 Jan 1;350:h846.

ObjectiveTo determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour.DesignMulticentre randomised controlled equivalence trial.Setting15 hospitals in the Netherlands.ParticipantsWomen with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used multiple imputation to correct for missing data.InterventionBefore the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour.Main Outcome MeasuresPrimary outcome was satisfaction with pain relief, measured hourly on a visual analogue scale and expressed as area under the curve (AUC), thus providing a time weighted measure of total satisfaction with pain relief. A higher AUC represents higher satisfaction with pain relief. Secondary outcomes were pain intensity scores, mode of delivery, and maternal and neonatal outcomes. Analysis was done by intention to treat. The study was defined as an equivalence study for the primary outcome.Results1414 women were randomised, of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia. Baseline characteristics were comparable. Pain relief was ultimately used in 65% (447/687) in the remifentanil group and 52% (347/671) in the epidural analgesia group (relative risk 1.32, 95% confidence interval 1.18 to 1.48). Cross over occurred in 7% (45/687) and 8% (51/671) of women, respectively. Of women primarily treated with remifentanil, 13% (53/402) converted to epidural analgesia, while in women primarily treated with epidural analgesia 1% (3/296) converted to remifentanil. The area under the curve for total satisfaction with pain relief was 30.9 in the remifentanil group versus 33.7 in the epidural analgesia group (mean difference -2.8, 95% confidence interval -6.9 to 1.3). For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group (mean difference -10.4, -13.9 to -7.0). The rate of caesarean section was 15% in both groups. Oxygen saturation was significantly lower (SpO2 <92%) in women who used remifentanil (relative risk 1.5, 1.4 to 1.7). Maternal and neonatal outcomes were comparable between both groups.ConclusionIn women in labour, patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief. Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia.Trial RegistrationNetherlands Trial Register NTR2551.© Freeman et al 2015.

This article appears in the collections: Interesting obstetric epidural articles and Is remifentanil for labour analgesia safe and effective?.

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