Ojo 2020.
Study characteristics | ||
Methods | Prospective, randomised, double‐blind controlled trial | |
Participants | Inclusion criteria: American Society of Anesthesiologists physical status II and III women >18 years of age, at gestational age >36 weeks, with singleton pregnancies, vertex presentation, in labour, desiring epidural labour analgesia at cervical dilation between 2 cm and 7 cm and reporting a verbal pain score >5 | |
Interventions | AMB (n = 61): Initial loading dose of 20 mL 0.1% ropivacaine with 2 µg/mL fentanyl then 6 mL programmed intermittent epidural boluses every 45 minutes with the first bolus administered 30 minutes after epidural initiation BI (n = 59): Initial loading dose of 20 mL 0.1% ropivacaine with 2 µg/mL fentanyl then 8 mL/h infusion beginning immediately after the loading dose |
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Outcomes | Rate of breakthrough pain with need for anaesthetic intervention Rate of caesarean delivery Rate of instrumental delivery Duration of labour Time‐weighted consumption of LA Maternal satisfaction Apgar scores |
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Notes | Study dates: November 2016 to November 2017 Funding sources not declared Conflicts of interest declared: A. S. Habib is a senior editor for Anesthesia and Analgesia |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by computer‐generated assignment: Quote: "After obtaining informed consent, subjects were allocated to a study arm (continuous epidural infusion or programmed intermittent epidural boluses) by computer‐generated random assignment placed in sequentially numbered sealed opaque envelopes." |
Allocation concealment (selection bias) | Low risk | Allocation concealment by sequentially numbered sealed opaque envelopes: Quote: "...placed in sequentially numbered sealed opaque envelopes." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Patient, anaesthesia provider and outcome assessor were blinded: Quote: "The patient, anesthesia provider, and outcome assessor were blinded to the randomization assignment." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded: Quote: "The patient, anesthesia provider, and outcome assessor were blinded to the randomization assignment." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Over 30% of study population excluded from analysis. |
Selective reporting (reporting bias) | Low risk | All a priori outcomes reported based on published protocol |
Other bias | Low risk | Appears to be free of other sources of bias. Sample size calculation: sample size of 44 women per group had 91% power to identify a difference in LA consumption based on pilot study |