Patient intermittent epidural boluses (PIEB) plus very low continuous epidural infusion (CEI) versus patient-controlled epidural analgesia (PCEA) plus continuous epidural infusion (CEI) in primiparous labour: a randomized trial.

Epidural maintenance technique for labour analgesia updates constantly. Thanks to infusion pumps, the recently developed programmed intermittent epidural bolus (PIEB) may reduce the use of anesthetic drugs and minimize unintended consequences such as cardio or neurotoxicity. Nevertheless, it is not yet a general practice. So far, there are no comparative studies in the literature that address levobupivacaine-based CEI + PCEA versus CEI + PIEB + PCEA. A randomized double-blind trial was carried out to evaluate if PIEB could reduce local anesthetic use compare to PCEA. Primiparous pregnant patients were divided into two groups: PIEB group (continuous infusion plus intermittent automatic doses) and PCEA group (continuous infusion plus PCEA). The primary objective was to analyze the differences between both groups regarding levobupivacaine total dose. The secondary objectives were to find out the differences concerning pain control, motor blockage, satisfaction score, labour time and delivery outcomes. Statistical analyses were done by protocol. The study recruited 200 patients (103 PIEB, 97 PCEA). The total dose administered was significantly higher in PIEB group: PCEA group 52.97 mg, IC 95% 45.65-60.28 mg and PIEB group 62.04 mg, IC 95% 55.46-68.61 mg (p = 0.021). PIEB group required fewer top up boluses (median value1; range 0-2) than CEI + PCEA group (median value 6; range 3-9) p < 0.05. Satisfaction scores were higher in PIEB group (p = 0.039, CI 95% 1.23-1.42). CEI + PIEB was found to be a good alternative to CEI + PCEA with very high rates of satisfaction in both groups although it was higher in PIEB group. PIEB group required fewer PCEA boluses. Further studies are needed to determine the best approach for epidural pain management.Clinical Trial Number and Registry URL: NCT03133091 ( https://clinicaltrials.gov/ct2/show/NCT03133091?term=MB+Rodriguez&rank=1) .

RCT Entities:   Population Interventions Outcomes