Routine labour epidural analgesia versus labour analgesia on request: a randomised non-inferiority trial

Area of Science:

• Obstetrics and Gynecology
• Anesthesiology
• Perinatal Care

Background:

• Epidural analgesia (EA) is commonly used for labor pain relief.
• The optimal timing and approach for EA administration (routine vs. on-demand) remain debated.
• Previous studies have not definitively established the impact of routine EA on delivery outcomes.

Purpose of the Study:

• To compare the mode of delivery between routine labor epidural analgesia (EA) and analgesia provided on request.
• To assess the non-inferiority of routine EA compared to on-demand EA regarding operative delivery rates.
• To evaluate labor characteristics and maternal/neonatal adverse outcomes associated with both EA approaches.

Main Methods:

• A randomized non-inferiority trial was conducted in two Dutch hospitals.
• 488 women with singleton pregnancies in cephalic presentation were randomized to routine EA or analgesia on request.
• Intention-to-treat (ITT) and per-protocol (PP) analyses were used to compare operative delivery rates and adverse events.

Main Results:

• Routine EA did not demonstrate non-inferiority; operative delivery rates were higher in the routine EA group (34.8% ITT, 8.9% PP difference).
• The upper confidence interval for the difference in operative deliveries exceeded the non-inferiority margin of +10%.
• Maternal adverse effects, including hypotension and motor blockade, were significantly more frequent in the routine EA group.

Conclusions:

• Routine epidural analgesia (EA) could not be established as non-inferior to on-demand analgesia.
• Routine EA use is associated with an increased rate of operative deliveries and maternal adverse effects.
• The findings do not support the routine implementation of epidural analgesia in labor.