Programmierte Intermittierende Epidurale Bolusapplikation versus kontinuierliche Applikation bei der patientenkontrollierten Epiduralanalgesie nach radikaler gynäkologischer Tumorchirurgie - Eine randomisierte, dreifach verblindete klinische Studie

Background: Continuous epidural infusion (CEI) is the standard application mode for epidural analgesia. A modified application mode, the programmed intermittent epidural bolus application (PIEB), showed reduced local anesthetic consumption and improved patient satisfaction in obstetric analgesia. Objective: To compare postoperative analgesia quality, local anesthetic consumption, as well as side effects of PIEB and CEI mode after major gynecological surgery. Methods: 60 patients with surgery under combined epidural and general anesthesia were randomized to 2 groups. In the CEI group basal medication was given with a continuous epidural dose of 6 ml/h ropivacaine 0.2 %; in the PIEB group, this dose was injected hourly at a bolus at a rate of 210 ml/h. In addition to basal medication, patient-controlled bolus administration with a bolus volume of 4ml and a lock-out time of 30min was possible in both groups. Data on local anesthetic consumption, pain scores, satisfaction side effects were collected until the evening of the second postoperative day. Results: 41 data sets were included in the intention-to-treat analysis (CEI: n = 20, PIEB: n = 21). There was no significant group difference (PIEB: 12 ml (6-32ml) vs CEI: 28ml (5-44ml, p=0.244) for the primary endpoint "cumulative PCEA bolus volume until day 2". Total volume was significantly reduced in the PIEB group compared to the CEI group (PIEB: 306 ml (259- 322.1 ml) vs. CEI: 355 ml (330.1-379.7 ml), p = 0.004), as well as the used basal volume (PIEB: 306ml (259ml) 322.1ml), CEI: 325.7ml (314.2-337.8ml), p = 0.005) Pain scores and satisfaction were comparable at each time point in both groups. There were no clinically relevant differences with regard to side effects such as postoperative nausea or vomiting, hypotension, and motor impairment. Conclusion: The programmed intermittent epidural application was found to be an effective analgesic procedure with reduced total ropivacaine consumption in this study. The PCEA bolus volume reduction, analgesia quality, and reported adverse events did not show any clinically relevant benefits over the continuous mode.