Abstract
INTRODUCTION: Epidural analgesia-related maternal fever (ERMF) affects 15%-25% of parturients, posing risks to both maternal and neonatal. Although ERMF's mechanisms remain unclear, non-infectious inflammatory responses and thermoregulatory disruption are implicated. Previous studies suggest that room-temperature local anaesthetic solutions administered during epidural analgesia may contribute to ERMF by altering spinal thermoregulation. This trial investigates whether warming local anaesthetic solutions to body temperature reduces ERMF incidence. METHODS AND ANALYSIS: This two-centre, double-blind, randomised controlled trial will enrol 424 parturients undergoing epidural analgesia for trial of labour. Participants will be randomised (1:1) to receive either body temperature (approximately 37°C) or room temperature (approximately 23°C) local anaesthetic solutions (0.1% ropivacaine with 0.5 µg/mL sufentanil). The primary outcome is intrapartum fever incidence, defined as oral temperature ≥38°C. Secondary outcomes include time to visual analogue scale ≤3, pulse perfusion index, maternal and neonatal antibiotic use rate, incidence of bacteraemia, intrapartum hypothermia, duration of labour, unplanned caesarean section rate, umbilical artery potential of hydrogen and Apgar scores at 1 and 5 min for newborns. Randomisation, stratified by study centre, employs permuted blocks via R software. Blinding is maintained for participants, outcome assessors and statisticians. A sample size of 424 participants (212 per group) provides 80% power (α=0.05) to detect a reduction in fever incidence from 21% to 10%. The primary analysis will be conducted in accordance with the intention-to-treat principle, with a secondary per-protocol analysis. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2023367-2) and the Ethics Committee of Suzhou Municipal Hospital (Approval No. K-2024-258 K01), and adheres to the Declaration of Helsinki. All participants will provide written informed consent. Results will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT06682416.