Abstract
BACKGROUND: Continuous epidural infusion (CEI) is the standard application setting for epidural infusion. A new mode, the programmed intermittent epidural bolus (PIEB) technique, showed reduced local anesthetic (LA) consumption and improved analgesia in obstetric analgesia. Goal of this trial was to evaluate the effects of PIEB versus CEI [combined with patient-controlled bolus (PCEA)] on LA consumption and pain scorings in major abdominal cancer surgery. METHODS: Following ethical approval, patients scheduled for major abdominal cancer surgery under general anesthesia in combination with epidural analgesia were randomized to receive either a PIEB mode of 6 mL/h or a CEI mode set at 6 mL/h of ropivacaine 0.2%, both combined with a PCEA mode set at a 4 mL bolus. LA consumptions and pain scorings were documented until the second postoperative evening. RESULTS: Eighty-four datasets were analyzed (CEI: n = 40, PIEB: n = 44). Regarding the primary endpoint, cumulative LA PCEA bolus volumes until day 2 differed significantly between the groups [PIEB 10 mL (2-28 mL) versus CEI, 28 mL (12-64 mL), median (25th-75th percentiles), p = 0.002]. Overall, LA consumption volumes were significantly lower in the PIEB group versus in the CEI group [PIEB: 329 mL (291-341 mL) vs. CEI: 350 mL (327-381 mL), p = 0.003]. Pain scores were comparable at each time point. CONCLUSIONS: This trial demonstrates reduced needs for PCEA bolus in the PIEB group. There were no clinically relevant benefits regarding morphine consumption, pain scorings, or other secondary outcome parameters. TRIAL REGISTRATION: This study has been registered retrospectively in the ClinicalTrials.gov registry ( NCT03378804 ), date of registration: December, 20th 2017.