C F Weiniger1, Y Ginosar, U Elchalal, H Y Sela, C Weissman, Y Ezra. 1. Department of Anesthesiology and Critical Care Medicine, Hadassah-Hebrew University Medical Centre, Ein Kerem, Jerusalem 91120, Israel. carolynfweiniger@gmail.com
Abstract
BACKGROUND: Neuraxial analgesia significantly increases the success rate of external cephalic version (ECV) among nulliparae. The study objective was to compare ECV success among multiparae with and without spinal analgesia. METHODS: Prospective randomized controlled trial performed over a pre-defined 6 yr period in a tertiary referral delivery suite. Healthy multiparae at term requesting ECV for breech presentation, without fetal or uterine anomaly, were enrolled after written informed consent. Women were randomized to receive either spinal analgesia (bupivacaine 7.5 mg) or no analgesia before the ECV. The primary outcome was successful conversion from breech to vertex presentation, confirmed by ultrasound. Visual analogue pain score and adverse outcomes (complications of anaesthesia or ECV) were recorded. Statistical analysis was performed according to intention to treat using two-sided tests. RESULTS: Among 265 multiparae who underwent ECV, 65 consented to enrol, one subsequently refused ECV; therefore, data from 64 women were analysed. ECV was successful in 27 of 31 patients (87.1%) receiving spinal analgesia vs 19 of 33 (57.5%) with no analgesia (P=0.009; 95% CI of difference: 0.075-0.48). ECV with spinal analgesia reduced visual analogue pain score, mean (sd) 1.7 (2.4) vs 5.5 (2.9) without (P<0.0001). Maternal hypotension was seen after spinal analgesia in 10 of 31 (32%) (P=0.0003) and easily treated without adverse outcome. No complications were noted after the ECV. CONCLUSIONS: Administration of spinal analgesia significantly increased the rate of successful ECV among multiparae at term with increased patient comfort. The trial was registered at the National Institute of Health Trials Registry, NCT00119184, www.clinicaltrials.gov.
RCT Entities:
BACKGROUND: Neuraxial analgesia significantly increases the success rate of external cephalic version (ECV) among nulliparae. The study objective was to compare ECV success among multiparae with and without spinal analgesia. METHODS: Prospective randomized controlled trial performed over a pre-defined 6 yr period in a tertiary referral delivery suite. Healthy multiparae at term requesting ECV for breech presentation, without fetal or uterine anomaly, were enrolled after written informed consent. Women were randomized to receive either spinal analgesia (bupivacaine 7.5 mg) or no analgesia before the ECV. The primary outcome was successful conversion from breech to vertex presentation, confirmed by ultrasound. Visual analogue pain score and adverse outcomes (complications of anaesthesia or ECV) were recorded. Statistical analysis was performed according to intention to treat using two-sided tests. RESULTS: Among 265 multiparae who underwent ECV, 65 consented to enrol, one subsequently refused ECV; therefore, data from 64 women were analysed. ECV was successful in 27 of 31 patients (87.1%) receiving spinal analgesia vs 19 of 33 (57.5%) with no analgesia (P=0.009; 95% CI of difference: 0.075-0.48). ECV with spinal analgesia reduced visual analogue pain score, mean (sd) 1.7 (2.4) vs 5.5 (2.9) without (P<0.0001). Maternal hypotension was seen after spinal analgesia in 10 of 31 (32%) (P=0.0003) and easily treated without adverse outcome. No complications were noted after the ECV. CONCLUSIONS: Administration of spinal analgesia significantly increased the rate of successful ECV among multiparae at term with increased patient comfort. The trial was registered at the National Institute of Health Trials Registry, NCT00119184, www.clinicaltrials.gov.
Authors: Javier Sánchez-Romero; Jesús López-Pérez; Ana Belén Flores-Muñoz; María Josefa Méndez-Martínez; Fernando Araico-Rodríguez; Jaime Mendiola-Olivares; José Eliseo Blanco-Carnero; Luis Falcón-Araña; Aníbal Nieto-Díaz; María Luisa Sánchez-Ferrer Journal: J Clin Med Date: 2022-01-19 Impact factor: 4.241