Prophylactic intravenous ephedrine to minimize fetal bradycardia after combined spinal-epidural labour analgesia: a randomized controlled study

Abstract

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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“…Later, ephedrine can also be used for neuropathic oedema although it is not licensed but indicated in the British National Formularies (BNF). Emerging clinical trials are investigating therapeutic potential in other diseases such as labour pain, vasopressors, and preeclampsia [ 23 , 24 , 25 ]. Another example is atropine, which in 2001 had licenses with the Medicines and Healthcare products Regulatory Agency (MHRA) for treatment like bradycardia and prevention of cholinergic effects on the heart after surgery.…”

The 90% Effective Dose of Sufentanil for Epidural Analgesia in the Early First Stage of Labor: A Double-blind, Sequential Dose-Finding Study

“…Hypotension after analgesia was defined as having an SAP < 80% of the baseline value and was treated with administration of a bolus dose of ephedrine 6 mg. Maternal bradycardia was defined as HR < 50 beats/min and was treated with atropine 0.5 mg. Fetal bradycardia was defined as an abrupt decrease in FHR of > 15 beats/min below the baseline for at least 60 seconds and occurring within the first 30 minutes after analgesia. 7 If fetal bradycardia was detected, intrauterine resuscitation was performed, including posture change, rapid IV fluid administration, high flow mask oxygen, IV atropine or ephedrine administration, terbutaline administration, or emergency cesarean section, by midwives, anesthesiologists, or obstetricians to ensure the safety of the fetus. The patient-controlled epidural analgesia (PCEA) pump (AM3300, Ace Medical Equipment Inc, Seoul, Korea) with continuous epidural infusion mode was connected to the epidural catheter once the VAS score was > 30 mm at 15, 30, or 45 minutes after epidural administration.…”

Neuraxial Methods of Pain Relief in Labor

“…Первое упоминание о применении КСЭА датируется 1981 г на операциях кесарева сечения [7] В последующем методика завоевала доверие и стала применяться в качестве анальгезии во время родов Выполнение КСЭА возможно как на одном уровне (через специальную эпидуральную иглу проводится игла для спинальной анальгезии интратекально), так и на двух, когда для эпидуральной и спинальной игл выбираются разные межпозвоночные промежутки [12] КСЭА объединяет преимущества СА и ЭА: быстрое наступление хорошего обезболивающего эффекта с возможностью пролонгировать его действие [12,13] По сравнению с ЭА нет статистически значимых различий по продолжительности родов, частоте оперативных родов, отмечается меньшая частота неудовлетворенности матери обезболиванием, но чаще наблюдаются гипотензия и зуд у роженицы, связанный с применением опиоидов [27] Также у пациенток, обезболенных методом КСЭА, в сравнении с ЭА, выше риск брадикардии плода без значимого влияния на неонатальный исход [13,26], при этом профилактическое введение эфедрина неэффективно [20] По данным исследования N Patel et al [40], при использовании низких доз анестетиков при КСЭА и ЭА (раствор бупивакаина 0,1% + фентанил 2 мкг/мл) различий по частоте возникновения брадикардии у плода, оценке новорожденного по шкале Апгар, кислотно-основному состоянию артериальной и венозной крови пуповины не наблюдалось Несмотря на интуитивно предполагаемое увеличение частоты постпункционной головной боли и инфекционных осложнений при КСЭА, значимых различий по данным осложнениям по сравнению с ЭА не выявлено [27] Спинальная…”