BACKGROUND: Programmed intermittent epidural boluses may improve the spread of local anesthetics compared to continuous epidural infusion, improving labor analgesia and obstetric outcomes. However, there are limited data from studies using commercially available pumps capable of coadministering programmed intermittent epidural boluses or continuous epidural infusion with patient-controlled epidural analgesia. Therefore, we performed this prospective, randomized, double-blind study to compare the impact of programmed intermittent epidural boluses versus continuous epidural infusion on labor analgesia and maternal/neonatal outcomes. We hypothesized that programmed intermittent epidural boluses will result in lower patient-controlled epidural analgesia consumption compared to that with continuous epidural infusion. METHODS: Following standardized initiation of epidural labor analgesia, women were randomized to receive 0.1% ropivacaine with 2 µg/mL fentanyl as 6-mL programmed intermittent epidural boluses every 45 minutes or continuous epidural infusion at 8 mL/h in a double-blind fashion with similar patient-controlled epidural analgesia settings in both groups. The primary outcome was patient-controlled epidural analgesia consumption per hour. Secondary outcomes included a need for physician interventions, patterns of patient-controlled epidural analgesia use, motor blockade, number of patients who developed hypotension, pain scores, duration of second stage of labor, mode of delivery, and maternal satisfaction. RESULTS: We included 120 patients (61 in programmed intermittent epidural boluses group and 59 in continuous epidural infusion group) in the analysis. The median (interquartile range) patient-controlled epidural analgesia volume consumed per hour was not significantly different between the groups: 4.5 mL/h (3.0-8.6 mL/h) for the continuous epidural infusion group and 4.0 mL/h (2.2-7.1 mL/h) for the programmed intermittent epidural boluses group (P = .17). The Hodges-Lehmann location shift estimate of the difference (95% CI) from the continuous epidural infusion to the programmed intermittent epidural boluses group is 0.9 mL/h (-0.4 to 2.2 mL/h). There were also no significant differences between the groups in any of the secondary outcomes except for higher median (interquartile range) patient-controlled epidural analgesia attempts per given ratio per hour in the programmed intermittent epidural bolus group (0.17 [0.10-0.30] vs 0.12 [0.08-0.18]; P = .03) and more motor block in the continuous epidural infusion group (those with Bromage score <5, 27.5% vs 50.0%; P = .03). CONCLUSIONS: Under the conditions of our study, we did not find improved outcomes with programmed intermittent epidural boluses compared to continuous epidural infusion except for less motor block with programmed intermittent epidural boluses. Future studies should assess whether smaller but clinically important differences exist and evaluate different parameters of programmed intermittent epidural boluses to optimize analgesia and outcomes with this mode of analgesia.
RCT Entities:
BACKGROUND: Programmed intermittent epidural boluses may improve the spread of local anesthetics compared to continuous epidural infusion, improving labor analgesia and obstetric outcomes. However, there are limited data from studies using commercially available pumps capable of coadministering programmed intermittent epidural boluses or continuous epidural infusion with patient-controlled epidural analgesia. Therefore, we performed this prospective, randomized, double-blind study to compare the impact of programmed intermittent epidural boluses versus continuous epidural infusion on labor analgesia and maternal/neonatal outcomes. We hypothesized that programmed intermittent epidural boluses will result in lower patient-controlled epidural analgesia consumption compared to that with continuous epidural infusion. METHODS: Following standardized initiation of epidural labor analgesia, women were randomized to receive 0.1% ropivacaine with 2 µg/mL fentanyl as 6-mL programmed intermittent epidural boluses every 45 minutes or continuous epidural infusion at 8 mL/h in a double-blind fashion with similar patient-controlled epidural analgesia settings in both groups. The primary outcome was patient-controlled epidural analgesia consumption per hour. Secondary outcomes included a need for physician interventions, patterns of patient-controlled epidural analgesia use, motor blockade, number of patients who developed hypotension, pain scores, duration of second stage of labor, mode of delivery, and maternal satisfaction. RESULTS: We included 120 patients (61 in programmed intermittent epidural boluses group and 59 in continuous epidural infusion group) in the analysis. The median (interquartile range) patient-controlled epidural analgesia volume consumed per hour was not significantly different between the groups: 4.5 mL/h (3.0-8.6 mL/h) for the continuous epidural infusion group and 4.0 mL/h (2.2-7.1 mL/h) for the programmed intermittent epidural boluses group (P = .17). The Hodges-Lehmann location shift estimate of the difference (95% CI) from the continuous epidural infusion to the programmed intermittent epidural boluses group is 0.9 mL/h (-0.4 to 2.2 mL/h). There were also no significant differences between the groups in any of the secondary outcomes except for higher median (interquartile range) patient-controlled epidural analgesia attempts per given ratio per hour in the programmed intermittent epidural bolus group (0.17 [0.10-0.30] vs 0.12 [0.08-0.18]; P = .03) and more motor block in the continuous epidural infusion group (those with Bromage score <5, 27.5% vs 50.0%; P = .03). CONCLUSIONS: Under the conditions of our study, we did not find improved outcomes with programmed intermittent epidural boluses compared to continuous epidural infusion except for less motor block with programmed intermittent epidural boluses. Future studies should assess whether smaller but clinically important differences exist and evaluate different parameters of programmed intermittent epidural boluses to optimize analgesia and outcomes with this mode of analgesia.