Randomized Controlled Trial Multicenter Study Comparative Study
- Estelle Morau, Malaury Jaillet, Brigitte Storme, Erika Nogue, Martine Bonnin, Dominique Chassard, Dan Benhamou, Nicolas Nagot, and Christophe Dadure.
- From the Department of Anesthesiology and Critical Care Medicine, Hopital Universitaire Arnaud de Villeneuve, Montpellier (EM, MJ, CD), Department of Anesthesiology and Critical Care Medicine Pôle Anesthesie-Reanimation-Estaing, Clermont-Ferrand (BS, MB), Clinical Research and Epidemiology Unit, Medical Information Department, Hopital Universitaire Montpellier, Montpellier (EN, NN), Department of Anesthesiology and Intensive Care, Hopital Universitaire Femme Me[Combining Grave Accent]re Enfant, Hospices Civils de Lyon, Lyon (DC) and Department of Anesthesiology and Critical Care Medicine, Hopitaux Universitaires Paris-Sud, AP-HP, Paris, France (DB).
- Eur J Anaesthesiol. 2019 Oct 1; 36 (10): 755-762.
BackgroundEpidural analgesia may change the mechanics of childbirth. These changes are related to the concentration of the local anaesthetic used epidurally but probably also to its mode of delivery into the epidural space.ObjectiveTo determine whether the administration of programmed intermittent epidural boluses (PIEB) improves the mechanics of second-stage labour compared with patient-controlled epidural analgesia (PCEA) with a background infusion.DesignA randomised, controlled, triple-blind study.SettingMulticentre study including four level III maternity units, January 2014 until June 2016.PatientsA total of 298 nulliparous patients in spontaneous labour were randomised to a PIEB or PCEA group.InterventionAfter epidural initiation with 15 ml of 0.1% levobupivacaine containing 10 μg of sufentanil, patients received either an hourly bolus of 8 ml (PIEB) or a continuous rate infusion of 8 ml h (PCEA): the drug mixture used was levobupivacaine 0.1% and sufentanil 0.36 μg ml.Main Outcome MeasuresThe primary outcome was a composite endpoint of objective labour events: a posterior occiput position in the second stage, an occiput position at birth, waiting time at full cervical dilatation before active maternal pushing more than 3 h, maternal active pushing duration more than 40 min, and foetal heart rate alterations. Vaginal instrumental delivery rates, analgesia and motor blockade scores were also recorded.ResultsFrom the 298 patients randomised, data from 249 (124 PIEB, 125 PCEA) were analysed. No difference was found in the primary outcome: 48.0% (PIEB) and 45.5% (PCEA) of patients, P = 0.70. In addition, no difference was observed between the groups for each of the individual events of the composite endpoint, nor in the instrumental vaginal delivery rate, nor in the degree of motor blockade. Despite an equivalent volume of medication in the groups, a significantly higher analgesia score at full dilatation was observed in the PIEB group, odds-ratio = 1.9 (95% confidence interval, 1.0 to 3.5), P = 0.04.ConclusionThe mechanics of the second stage did not differ whether PIEB or PCEA was used. Analgesic conditions appeared to be superior with PIEB, especially at full dilation.Trial RegistrationNCT01856166.
This article appears in the collection: Programmed Intermittent Epidural Bolus for Labour Analgesia.
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