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Study Finds Remifentanil Patient Controlled Analgesia Not as Effective as Epidural Analgesia in Managing Pain Relief during Labor

In a study to be presented on Feb. 7 at 1:30 p.m. CST, at the Society for Maternal-Fetal Medicine’s annual meeting, The Pregnancy Meeting™, in New Orleans, researchers will report findings which suggest remifentanil patient controlled analgesia is not equivalent to epidural analgesia for pain, pain appreciation scores, and overall satisfaction in women who request for pain relief during labor.

Remifentanil patient controlled analgesia (RPCA) is a short-acting pain reliever, an opiate, similar to pethidine. It relieves pain rapidly, but also wears off very quickly, which makes it very suitable for administration through patient controlled analgesia. With RPCA the patient can give herself a dose of remifentanil intravenously every few minutes. Recent studies suggested that RCPA was equal to epidural analgesia (EA) in regards to satisfaction with pain relief, so this study, titled Remifentanil patient controlled analgesia versus epidural analgesia in labor; a randomized controlled equivalence trial set out to compare the effectiveness.

Pain appreciation was measured hourly on a visual analogue scale, and expressed as area under the curve (AUC). The AUC gives a time-weighted measure of total pain appreciation. It was calculated for the duration of labor and for the time that pain relief was administered. A higher AUC for pain appreciation represents higher satisfaction with pain relief.

For the study, 709 women were allocated to RPCA and 705 to EA. They were randomly chosen from healthy pregnant women who intended to deliver vaginally at 15 different hospitals in the Netherlands. Four hundred forty-seven women in the RPCA and 343 in the EA group received pain relief during labor. Among women allocated to RPCA, 344 received nothing but RPCA; in the EA group 295 received just EA. Thirteen percent of the women switched to EA after RPCA. The AUC for total pain appreciation during labor was 26.5 in the RPCA group versus 36.0 in the EA group.

“Recent studies suggest that remifentanil patient controlled analgesia (RPCA) is equivalent to epidural analgesia (EA) with respect to pain appreciation (satisfaction with pain relief). The aim of our study was to compare the effectiveness of RPCA with EA regarding pain appreciation,” said Liv Freeman, M.D., one of the study’s authors.

“The results of the study show that RPCA is not equivalent to EA with respect to pain appreciation, i.e. satisfaction with pain relief. Pain appreciation scores in women, who requested pain relief during labor, randomized to EA, are significantly better.”

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A copy of the abstract is available at http://www.smfmnewsroom.org and below.  For interviews please contact Vicki Bendure at Vicki@bendurepr.com 202-374-9259 (cell), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is the premiere membership organization for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by sharing expertise through continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual meeting in which groundbreaking new ideas and research in the area of maternal-fetal medicine are shared and discussed.  For more information visit www.smfm.org.

Abstract 54: Remifentanil patient controlled analgesia versus epidural analgesia in labor; a randomized controlled equivalence trial.

Authors: Liv Freeman1, Kitty Bloemenkamp1, Maureen Franssen2, Dimitri Papatsonis3, Markus Hollmann4, Mallory Woiski5, Martina Porath6, Hans van den Berg7, Erik van Beek8, Nico Schuitemaker9, Marko Sikkema10, Sabine Logtenberg11, Martijn Oudijk12, Caroline Bax13, Paulien van der Salm14, Elske van den Akker-van Marle15, Saskia le Cessie16, Jan van Lith1, Michel Struys17, Albert Dahan18, Ben Willem Mol19, Johanna Middeldorp1 

1Leiden University Medical Center, Obstetrics, Leiden, Netherlands, 2University Medical Center Groningen, Obstetrics and Gynecology, Groningen, Netherlands, 3Amphia Hospital, Obstetrics and Gynecology, Breda, Netherlands, 4Academic Medical Center, Anesthesiology, Amsterdam, Netherlands, 5St. Radboud University Medical Center, Obstetrics and Gynecology, Nijmegen, Netherlands, 6Maxima Medical Center, Obstetrics and Gynecology, Veldhoven, Netherlands, 7Maxima Medical Centre, Anesthesiology, Veldhoven, Netherlands, 8St. Antonius Hospital, Obstetrics and Gynecology, Nieuwegein, Netherlands, 9Diakonessen Hospital, Obstetrics and Gynecology, Utrecht, Netherlands, 10Hospital Group Twente, Obstetrics and Gynecology, Almelo, Netherlands, 11Onze Lieve Vrouwe Gasthuis, Obstetrics and Gynecology, Amsterdam, Netherlands, 12University Medical Center Utrecht, Obstetrics and Gynecology, Utrecht, Netherlands, 13VU Medical Center, Obstetrics and Gynecology, Amsterdam, Netherlands, 14Meander Medical Center, Obstetrics and Gynecology, Amersfoort, Netherlands, 15Leiden Univerity Medical Center, Department of Medical Decision making, Leiden, Netherlands, 16Leiden University Medical Center, Department of Medical Statistics, Leiden, Netherlands, 17UMCG, Anesthesiology, Groningen, Netherlands, 18LUMC, Anesthesiology, Leiden, Netherlands, 19Academic Medical Center, Obstetrics and Gynecology, Amsterdam, Netherlands

Objective: Recent studies suggest that remifentanil patient controlled analgesia (RPCA) is equivalent to epidural analgesia (EA) with respect to pain appreciation (satisfaction with pain relief). These studies were underpowered to detect a difference in pain appreciation. The aim of our study was to compare the effectiveness of RPCA with EA regarding pain appreciation.

Study Design: We performed a multicenter equivalence RCT in 15 hospitals in the Netherlands (NTR 2551). We included healthy pregnant women who intended to deliver vaginally. After informed consent, they were randomized prior to the onset of active labor. Primary outcome was pain appreciation, measured hourly on a visual analogue scale (VAS), and expressed as area under the curve (AUC). The AUC gives a time-weighted measure of total pain appreciation. The AUC was calculated for the duration of labor and for the time that pain relief was administered. A higher AUC for pain appreciation represents higher satisfaction with pain(relief). Secondary outcomes were pain scores and maternal and neonatal variables. To exclude a clinically significant difference in pain appreciation, defined as a difference of more than 10%, we needed 1136 women. Analysis was done by intention to treat.

Results: 709 women were allocated to RPCA and 705 to EA. Baseline characteristics were comparable. 447 (65%) women in the RPCA and 343 (51%) in the EA group received pain relief during labor (RR 1.3 95% CI 1.2-1.5). Among women allocated to RPCA 344 received nothing but RPCA, in the EA group 295 received just EA. 13% of the women switched to EA after RPCA. Maternal and neonatal outcomes were comparable. No serious adverse events occurred. The AUC for total pain appreciation during labor was 26.5 in the RPCA group versus 36.0 in the EA group (mean difference 9.5 (95% CI 5.0-13.0)).

Conclusion: RPCA is not equivalent to EA with respect to AUC for pain and pain appreciation scores and overall satisfaction in women with a request for pain relief during labor.

 

Area under the curve of pain appreciation scores, pain scores and overall appreciation score. Intention to treat analysis; analysis of scores during active labor and separate analysis of scores during administration of pain relief.

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