Slm Logtenberg1, K Oude Rengerink1, C J Verhoeven2,3, L M Freeman4, Esa van den Akker5, M B Godfried6, E van Beek7, Owhm Borchert8, N Schuitemaker9, Ecsm van Woerkens10, I Hostijn11, J M Middeldorp4, J A van der Post1, B W Mol12. 1. Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, the Netherlands. 2. Department of Midwifery Science, AVAG/EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands. 3. Maxima Medical Centre, Veldhoven, the Netherlands. 4. Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands. 5. Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands. 6. Department of Anesthesiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands. 7. Department of Obstetrics and Gynaecology, St Antonius Hospital, Nieuwegein, the Netherlands. 8. Department of Anaesthesiology, St Antonius Hospital, Nieuwegein, the Netherlands. 9. Department of Obstetrics and Gynaecology, Diakonessen Hospital, Utrecht, the Netherlands. 10. Department of Anaesthesiology, Diakonessen Hospital, Utrecht, the Netherlands. 11. Midwifery Practice Alnatal, Nieuwegein, the Netherlands. 12. The Robinson Research Institute School of Medicine, University of Adelaide and The South Australian Health and Medical Research Institute Adelaide Australia, Adelaide, SA, Australia.
Abstract
OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the Netherlands. POPULATION: A total of 408 pregnant women at low risk for obstetric complications initially under the care of primary-care midwives. METHODS: Women randomised before active labour to receive analgesia with RPCA or EA, if requested. MAIN OUTCOME MEASURES: Primary outcome was satisfaction with pain relief measured hourly using a visual analogue scale and summed as area under the curve (AUC). Secondary outcomes were overall satisfaction with pain relief, pain intensity scores during labour, mode of delivery, and maternal and neonatal outcomes. RESULTS: We randomised 418 women, of whom 409 could be followed for the primary endpoint. Analgesia was received by 46% (94/203) in the remifentanil group and 37% (76/206) in the epidural group. The AUC for satisfaction with pain relief was 32 in the remifentanil group and 31 in the epidural group (mean difference -0.50; 95% CI -6.8 to 5.9). Among women who actually received analgesia, these values were 23 and 35, respectively (mean difference -12; 95% CI -22 to -1.5). Secondary outcomes were comparable. CONCLUSIONS: In low-risk labouring women, we could not demonstrate equivalence between a strategy with RPCA to EA with respect to satisfaction with pain relief assessed during the total duration of labour. However, once applied satisfaction was higher in women who received epidural analgesia. TWEETABLE ABSTRACT: Satisfaction with pain relief is higher in women receiving epidural analgesia compared with Remifentanil PCA.
OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the Netherlands. POPULATION: A total of 408 pregnant women at low risk for obstetric complications initially under the care of primary-care midwives. METHODS: Women randomised before active labour to receive analgesia with RPCA or EA, if requested. MAIN OUTCOME MEASURES: Primary outcome was satisfaction with pain relief measured hourly using a visual analogue scale and summed as area under the curve (AUC). Secondary outcomes were overall satisfaction with pain relief, pain intensity scores during labour, mode of delivery, and maternal and neonatal outcomes. RESULTS: We randomised 418 women, of whom 409 could be followed for the primary endpoint. Analgesia was received by 46% (94/203) in the remifentanil group and 37% (76/206) in the epidural group. The AUC for satisfaction with pain relief was 32 in the remifentanil group and 31 in the epidural group (mean difference -0.50; 95% CI -6.8 to 5.9). Among women who actually received analgesia, these values were 23 and 35, respectively (mean difference -12; 95% CI -22 to -1.5). Secondary outcomes were comparable. CONCLUSIONS: In low-risk labouring women, we could not demonstrate equivalence between a strategy with RPCA to EA with respect to satisfaction with pain relief assessed during the total duration of labour. However, once applied satisfaction was higher in women who received epidural analgesia. TWEETABLE ABSTRACT: Satisfaction with pain relief is higher in women receiving epidural analgesia compared with Remifentanil PCA.
Authors: A E Seijmonsbergen-Schermers; D C Zondag; M Nieuwenhuijze; T Van den Akker; C J Verhoeven; C Geerts; F Schellevis; A De Jonge Journal: BMC Pregnancy Childbirth Date: 2018-06-01 Impact factor: 3.007
Authors: Sabine L M Logtenberg; Corine J Verhoeven; Katrien Oude Rengerink; Anne-Marie Sluijs; Liv M Freeman; François G Schellevis; Ben Willem Mol Journal: BMC Pregnancy Childbirth Date: 2018-08-25 Impact factor: 3.007