Double dural puncture epidural improves quality of labour analgesia without increasing adverse effects in primipara: A randomised controlled trial.

Background: Neuraxial anaesthesia is considered a routine method of reducing labour pain. Over the past few decades, several improvements in neuraxial labour analgesia have been studied and evaluated.

Objective: This trial compared the analgesic effects and adverse effects between double dural puncture epidural (DDPE) and epidural for labour analgesia, and analysed the feasibility and safety of using DDPE for labour analgesia.

Design: A single-centre, prospective, single-blind, randomised controlled trial.

Setting: Huai'an First People's Hospital, affiliated to Nanjing Medical University, from June 2023 to March 2024.

Patients: One hundred and twenty primipara were randomised to the epidural group or the DDPE group.

Intervention: The DDPE group underwent two needle punctures of the dura/arachnoid membranes with a 25-gauge Whitacre needle introduced via the epidural needle: one cephalad and one caudad.

Main outcome measures: The primary outcome measure was the proportion of patients with adequate analgesia (VAS pain score ≤ 30 mm) 10 min after the neuraxial block (T1). Secondary outcome measures included block quality, adverse effects and maternal outcomes.

Results: DDPE had a higher percentage of adequate analgesia than epidural at T1 (75.0 vs. 40.0%, P  < 0.001) and at T3 (98.3 vs. 85.0%, P  = 0.017). Compared with epidural, lower DDPE pain VAS scores were also observed at T1 and T4: 26 [20 to 34.5] vs. 48 [26 to 59.5], P  < 0.001; and 36.5 [29 to 48.5] vs. 44.5 [30 to 59.8], P  = 0.01, respectively. In addition, compared with epidural, DDPE showed a faster onset of sacral coverage, 9 [8 to 13.5] vs. 16 [12 to 18] min, P  < 0.001; less need for additional analgesia, 8.3 vs. 25%, P  = 0.014; and lower drug consumption, 70 [50 to 90] vs. 80 [60 to 110] ml, P  = 0.005. Under the conditions of this study, there was no significant difference in adverse reactions between the DDPE and epidural groups ( P  > 0.05).

Conclusion: Compared with the epidural technique, DDPE showed significant advantages for the onset of labour analgesia and demonstrated good efficacy in sacral coverage, which may improve the quality of the neuraxial block and better meet the demand for rapid analgesia in labouring women. In terms of future research directions, comparative studies between DDPE and a single dural puncture epidural, and between DDPE and combined spinal epidural are areas worthy of further investigation.

Trial registration: Chinese Clinical Trials Registry (ChiCTR2300072727) https://www.chictr.org.cn .