Daniel Shatalin1, Cristian Arzola2, Kristi Downey2, Xiang Y Ye3, Jose C A Carvalho2. 1. Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, 600 University Avenue, Room 7-405, Toronto, ON, M5G 1X5, Canada. danielsmail@gmail.com. 2. Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto, 600 University Avenue, Room 7-405, Toronto, ON, M5G 1X5, Canada. 3. Department of Pediatrics, Micare Research Centre, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.
Abstract
PURPOSE: We studied the programmed intermittent epidural bolus (PIEB) time interval between boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 µg·mL-1 to produce effective analgesia in 90% of women (EI90) during the first stage of labour. METHODS: In a double-blind sequential allocation trial using a biased coin up-and-down design to determine the EI90, the PIEB boluses of 2.5 mL of 0.25% bupivacaine plus fentanyl 8 µg·mL-1 were delivered at varying intervals-60, 50, 40, and 30 min. The primary outcome was the adequate response of the patient to the PIEB regimen, defined as no use of supplemental analgesia for six hours or until the first stage of labour was completed, whichever came first. The secondary outcomes were the upper sensory block level to ice, motor block and hypotension. The isotonic regression with extrapolation approach was used to estimate the EI90. RESULTS: In the 20 women studied, the estimated EI90 was 20 (95% CI, 5.9 to 28.8) min. For the secondary outcomes, we classified women into those assigned to 30 min (16 women) and those assigned to more than 30 min (four women). The median upper sensory block for women in the 30-min group and more than 30 min were T6 (or T5) and T7, respectively. No participants experienced motor block. Hypotension occurred in one patient in the 30-min group. CONCLUSION: The estimated EI90 for boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 µg·mL-1 was 20 (95% CI, 5.9 to 28.8) min. These results suggest that there is no advantage in using this regimen compared with those reported in the literature using the same dose of bupivacaine in concentrations of 0.0625% and 0.125%. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT03735771); registered 7 November 2018.
RCT Entities:
PURPOSE: We studied the programmed intermittent epidural bolus (PIEB) time interval between boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 µg·mL-1 to produce effective analgesia in 90% of women (EI90) during the first stage of labour. METHODS: In a double-blind sequential allocation trial using a biased coin up-and-down design to determine the EI90, the PIEB boluses of 2.5 mL of 0.25% bupivacaine plus fentanyl 8 µg·mL-1 were delivered at varying intervals-60, 50, 40, and 30 min. The primary outcome was the adequate response of the patient to the PIEB regimen, defined as no use of supplemental analgesia for six hours or until the first stage of labour was completed, whichever came first. The secondary outcomes were the upper sensory block level to ice, motor block and hypotension. The isotonic regression with extrapolation approach was used to estimate the EI90. RESULTS: In the 20 women studied, the estimated EI90 was 20 (95% CI, 5.9 to 28.8) min. For the secondary outcomes, we classified women into those assigned to 30 min (16 women) and those assigned to more than 30 min (four women). The median upper sensory block for women in the 30-min group and more than 30 min were T6 (or T5) and T7, respectively. No participants experienced motor block. Hypotension occurred in one patient in the 30-min group. CONCLUSION: The estimated EI90 for boluses of 2.5 mL of bupivacaine 0.25% with fentanyl 8 µg·mL-1 was 20 (95% CI, 5.9 to 28.8) min. These results suggest that there is no advantage in using this regimen compared with those reported in the literature using the same dose of bupivacaine in concentrations of 0.0625% and 0.125%. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT03735771); registered 7 November 2018.