Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

Abstract

BackgroundPain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments.Methods/designThe proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia.Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief.Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects.The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared.DiscussionThis study, considering cost effectiveness of remifentanil as first choice analgesia 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 labour, 24 hours a day.Trial registration numberDutch Trial Register NTR2551, http://www.trialregister.nl

Remifentanil as an alternative to epidural analgesia for vaginal delivery: A meta-analysis of randomized trials

“…R-PCA reduced the incidence of pruritus when compared with EA, (OR 0.54; 95% CI, 0.32-0.89). Among the 5 studies that reported pruritus, Douma et al [8] used sufentanil, Freeman et al [14] used fentanyl or sufentanil, while the remainder [9][10]12,15] used fentanyl as an epidural opioid. Although the mechanism of neuraxial opioid-induced pruritus remains unclear, it is has been suggested that there may be activation of an itch center in the central nervous system and the medullary dorsal horn, potentially combined with antagonism of inhibitor itch transmitters [24].…”

“…Maternal satisfaction with labor analgesia was reported in all 6 studies [8][9][10][11][12][13][14][15]. However, the definition and methods of reporting satisfaction differed across the studies ( Table 2).…”

“…In Douma et al [8], Volmanen et al [13], and Freeman et al [14] hypoxemia was defined as saturation b95%. In Tveit et al [12] and Rabie et al [15] hypoxemia was defined as saturation b 92%, and Stocki et al [10] as below 94%, respectively, where supplemental oxygen was given.…”

Técnicas analgésicas para el parto: alternativas en caso de fallo de la epidural

“…Debido a sus potenciales efectos adversos, es necesario informar a la paciente 103 , monitorizarla adecuadamente 104,105 y formar al personal de enfermería y matronas en su empleo. En Holanda, donde la analgesia epidural no está completamente extendida a toda la población, se ha llegado a recomendar la PCA de remifentanilo desde un punto de vista coste-efectividad como una técnica analgésica de primera elección 106 , aspecto que ha sido altamente criticado 107 . Los agonistas antagonistas (nalbufina, butorfanol, pentazocina y buprenorfina) también se han usado, siendo su principal ventaja el efecto techo respecto a las dosis que causan depresión respiratoria (ej.…”

Remifentanyl w łagodzeniu bólu porodowego

“…Remifentanil is used in 1/3 of all of the obstetric hospitals in Holland [37], in which guidelines of management and delivery analgesia protocols have been devised [38]. In Italy, a study was conducted with a group of 205 parturients receiving RMFNT, and no newborn required naloxone [39].…”