Background The combined spinal-epidural (CSE) technique for relief of labour pain offers both rapid onset and superior first-stage analgesia. Nevertheless, the known increased risk for early profound fetal bradycardia (EPFB) following CSE continues to be a concern that often limits its use. The purpose of this study was to determine if giving prophylactic intravenous ephedrine at the time of CSE administration would reduce EPFB.Methods We conducted this clinical trial at a large community hospital and enrolled healthy patients requesting epidural analgesia for labour. Patients were randomly assigned to receive either normal saline placebo or ephedrine 10 mg iv at the time of CSE. The primary outcome of EPFB (defined as bradycardia \ 90 beatsÁmin -1 for [ two minutes and occurring within the first 30 min after CSE) was compared between groups. The secondary outcomes included the incidence of urgent cesarean delivery, the requirement for additional doses of ephedrine, maternal blood pressure, uterine hypertonus and tachysystole, and abnormal fetal heart rate (FHR) patterns before and after CSE. Results There were 299 women randomized to the ephedrine (EPH) group and 297 randomized to the normal saline placebo (NS) group. There was no difference between groups in the incidence of EPFB (2.7% EPH group vs 4.7% NS group; relative risk, 0.57; 95% confidence interval, 0.24 to 1.33; P = 0.184). There was also no difference between groups in the incidence of -015-0450-8 urgent cesarean delivery, uterine hypertonus, uterine tachysystole, and abnormal FHR patterns. Conclusions We conclude that prophylactic intravenous ephedrine administration at the time of CSE during labour was ineffective at reducing the risk for EPFB associated with CSE. Nevertheless, a lower than expected rate of EPFB resulted in the trial being underpowered. This trial was registered at ClinicalTrials.gov, identifier: NCT02062801.123 Can J Anesth/J Can Anesth (2015) 62:1201-1208 DOI 10.1007/s12630 RésuméContexte La technique rachidienne et péridurale combinée (RPC) pour soulager la douleur lors de l'accouchement procure à la fois un court délai d'action et une analgésie supérieure pour la première étape du travail obstétrical. Cependant, le risque accru connu de bradycardie foetale profonde précoce (BFPP) après une RPC est une inquiétude qui contribue bien souvent à freiner son utilisation. L'objectif de cette étude était de déterminer si l'administration prophylactique d'éphédrine intraveineuse au moment de l'administration de la RPC réduisait la BFPP. Méthode Nous avons réalisé cette étude clinique dans un hô pital communautaire d'envergure et enrô lé des patientes ayant demandé une analgésie péridurale pour le travail obstétrical. Les patientes ont été aléatoirement réparties en deux groupes et ont reçu soit un placebo de sérum physiologique ou 10 mg iv d'éphédrine au moment de la RPC. Nous avons comparé notre critère d'évaluation principal, la BFPP (définie comme une bradycardie \ 90 battementsÁmin -1 pour [ 2 minutes et survenant au co...

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Background The combined spinal-epidural (CSE) technique for relief of labour pain offers both rapid onset and superior first-stage analgesia. Nevertheless, the known increased risk for early profound fetal bradycardia (EPFB) following CSE continues to be a concern that often limits its use. The purpose of this study was to determine if giving prophylactic intravenous ephedrine at the time of CSE administration would reduce EPFB.Methods We conducted this clinical trial at a large community hospital and enrolled healthy patients requesting epidural analgesia for labour. Patients were randomly assigned to receive either normal saline placebo or ephedrine 10 mg iv at the time of CSE. The primary outcome of EPFB (defined as bradycardia \ 90 beatsÁmin -1 for [ two minutes and occurring within the first 30 min after CSE) was compared between groups. The secondary outcomes included the incidence of urgent cesarean delivery, the requirement for additional doses of ephedrine, maternal blood pressure, uterine hypertonus and tachysystole, and abnormal fetal heart rate (FHR) patterns before and after CSE. Results There were 299 women randomized to the ephedrine (EPH) group and 297 randomized to the normal saline placebo (NS) group. There was no difference between groups in the incidence of EPFB (2.7% EPH group vs 4.7% NS group; relative risk, 0.57; 95% confidence interval, 0.24 to 1.33; P = 0.184). There was also no difference between groups in the incidence of Author contributions David R. Gambling, Miriam Bender, Sue Faron, and Thomas R. Farrell helped design the study. Miriam Bender, Sue Faron, and Thomas R. Farrell helped collect the data. David R. Gambling, Miriam Bender, and Sue Faron helped analyze the data and write the manuscript. David R. Gambling helped conduct the study. Sue Faron helped educate the nursing staff for study participation. Dale Glaser was involved in the statistical analysis, power analysis, proposed analysis, and the results. Thomas R. Farrell helped recruit patients and educate the nursing staff about the study protocol, and he reviewed the manuscript. All authors reviewed the analysis of the data.

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