Methods
allergy, scoliosis, fetal anomalies
ALLERGY, SCOLIOSIS
This single-center, double-blind, RCT was approved by the institutional review board at the University of Arkansas for Medical Sciences and was conducted between April 2019 and October 2022. This article adheres to the applicable Consolidated Standards of Reporting Trials (The authors recognize that there is a gender spectrum; however, all participants identified as women in this study, so we use this term throughout. We enrolled women with singleton pregnancies and American Society of Anesthesiologists physical status II or III who were scheduled for elective cesarean delivery. Participants were excluded if they were younger than 18 years, weighed more than 120 kg, were less than 150 cm tall, were unable to understand English, and had contraindications to neuraxial anesthesia, previous back surgery or scoliosis, severe fetal anomalies, or allergy to any study medications. Race and ethnicity were self-reported by the participants (Black, White, or other, which includes Asian, Hispanic ethnicity, and any other race or ethnicity not otherwise specified) and were included to assess the representativeness of the sample being studied.After providing written informed consent, participants were randomly assigned to receive either standard epidural or DPE. A computer-generated, 1:1 ratio randomization schedule with blocks of 10 was created by a research coordinator not involved in the study. Allocation assignments remained concealed using sequentially numbered, opaque, sealed envelopes. Before scheduled cesarean delivery, the proceduralist opened the envelope containing the group allocation. Epidural procedures were performed by the attending anesthesiologist or by residents under direct supervision of the attending anesthesiologist. The team performing the epidural technique had no other involvement in the study. The clinical team caring for the patient (obstetricians, anesthesiologists, and nurses), outcome assessors, data analyst, and study participants were blinded to randomization. A blinded investigator (N.S. or M.W.) assessed all perioperative outcomes.