Leo 2010.
Methods | Randomized controlled trial | |
Participants | Setting: recruited from KK Women's and Children's Hospital, Singapore Sample size: N = 62 Participants: age not provided Inclusion criteria: healthy ASA I nulliparous parturients with term (> 36 weeks of gestation), singleton fetuses in the vertex presentation, who were in early labour (cervical dilation < 5 cm) and requested labour epidural analgesia |
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Interventions | AMB (n = 31): 0.1% ropivacaine + fentanyl 2 µg/mL. PCEA algorithm initiated immediately after completion of CSE. Participants in this group received automated mandatory boluses (AMB) of 5 mL every hour instead of a basal infusion. The first AMB dose was delivered 30 min from CSE and epidural catheter placement and every hour subsequently if no PCEA demands were made. If the participant had made a successful PCEA self‐bolus, the next AMB bolus would be delivered 30 min after the last successful PCEA self‐bolus and every hour thereafter. The lockout period for both PCEA and AMB boluses was 10 min. If a PCEA demand was made within 10 min of an AMB dose, no further bolus would be given. This would be recorded as an unsuccessful PCEA attempt. PCEA bolus was set at 5 mL and maximal hourly limit at 20 mL/h (inclusive of basal infusion and automated boluses) BI (n = 31): 0.1% ropivacaine + fentanyl 2 μg/mL. PCEA with basal infusion 5 mL/h initiated immediately after intrathecal drug administration and epidural catheter placement. PCEA bolus was set at 5 mL, lockout interval at 10 min and maximal dose at 20 mL/h |
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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 Total LA/hour (time weighted hourly consumption of ropivacaine) Maternal satisfaction Apgar scores |
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Notes | Study dates not stated Funding sources not declared No conflict of interests declared References to other studies in this review: Chua 2004; Fettes 2006; Lim 2005; Sia 2007; Wong 2006 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number tables |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Independent assistant programmed the epidural drug delivery system according to group assignment. Parturients were subsequently monitored by a second anaesthesiologist not involved in performing the block. Neither the parturients nor the anaesthesiologists who monitored and collected post‐block data were aware of group assignments |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Neither the parturients nor the anaesthesiologists who monitored and collected post‐block data were aware of group assignments. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
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 30 participants in each group was calculated to detect a 30% reduction in the incidence of breakthrough pain requiring physician top‐up for participants in the PCEA + AMB arm compared with those in the PCEA + BI arm (α = 0.05, ß = 0.2) |