Pain management during labor: use of intermittent drug delivery devices for improvement of obstetric and neonatal outcome and reduction of healthcare burden: A large non-inferiority randomized clinical trial

Background: Automated continuous epidural administration of local anesthetics provides a more stable analgesic block with decreasing of healthcare staff compared to manual boluses administration (TOP-UP) but is associated to high rate of operative vaginal delivery. We hypothesized that the use of programmed intermittent automated boluses (PIEB) is able to provide a good quality of analgesia and decreasing of anesthesiologic workload without increasing the rate of instrumental vaginal birth in comparison with TOP-UP technique. Laboring nulliparous woman aged between 18 and 46 years were randomized to epidural analgesia with 0.0625% levobupivacaine and sufentanil administered by PIEB or by TOP-UP techniques. Primary outcome was instrumental vaginal delivery rate and secondary outcomes were quality of analgesia, total and time-related drugs doses used, motor block, newborn outcome, and anesthesiologic workload. Results: Six hundred twenty-nine were randomized, and 628 were included in the intention-to-treat analysis. The rate of instrumental vaginal delivery was similar in the PIEB and TOP-UP groups (13.2% vs 9.7%, OR 1.4 95% CI 0.8 to 2.5; p 0.21). There was no difference between groups regarding mode of delivery (cesarean section vs vaginal birth), newborn outcome, and motor block. Patients in the PIEB group received more total and time-related drugs doses and a better quality of analgesia. Anesthesiological workload was significantly reduced in the PIEB group. Conclusions: Our study demonstrated that epidural anesthesia with programmed intermittent epidural boluses by an automated device provides an effective and safe management of labor analgesia with improvement of pain control and sparing of man workload compared to manual top-up protocols.