A biased coin up-and-down sequential allocation trial to determine the optimum programmed intermittent epidural bolus time interval between 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL-1.

Abstract

The optimal epidural mixtures and settings for programmed intermittent epidural bolus (PIEB) labour analgesia have yet to be determined. A previous study by our group demonstrated that 10 mL boluses of bupivacaine 0.0625% with fentanyl 2 µg·mL-1 administered every 40 min provided effective analgesia during the first stage of labour for 90% of women, without breakthrough pain. We wanted to determine the effective PIEB time interval of 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL-1 under the same study circumstances, aiming at a future comparative study. This double-blind dose-finding study used the biased coin up-and-down sequential allocation method to determine the effective PIEB interval 90% (EI90) needed to provide effective analgesia without breakthrough pain during the first stage of labour. We used fixed 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg.mL-1 and studied time intervals of 60, 50, 40, and 30 min. The first patient was assigned an interval of 60 min and the remaining intervals were assigned as per the biased coin up-and-down method. The estimated EI90 was 36.5 min (95% confidence interval [CI], 34.0 to 39.0) by the truncated Dixon and Mood method and 34.2 min (95% CI, 30.8 to 41.5) by the isotonic regression method. We found that 20/40 women had an upper sensory block to ice above T6, 34/40 women had no motor block, and no woman required treatment for hypotension. The EI90 between 5 mL boluses of bupivacaine 0.125% with fentanyl 2 µg·mL-1 during the first stage of labour is approximately 35 min. www.clinicaltrials.gov (NCT #02758405); registered 2 May, 2016.