Chua 2004.
Study characteristics | ||
Methods | Parallel, randomiSed controlled trial | |
Participants | Setting: recruited from Singapore General Hospital, Singapore Sample size: N = 42 Participants: age not provided Inclusion criteria: ASA physical status I nulliparous women in early spontaneous labour pain with at least one contraction every 5 min who had requested neuraxial block |
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Interventions | AMB (n = 21): ropivacaine 0.1% plus fentanyl 2 µg/mL for maintaining epidural analgesia The initial 5 mL bolus was administered 30 min after time 0, followed by 5 mL boluses every hour thereafter. As the highest rate of delivery afforded by the pump was 100 mL/h, each epidural bolus was delivered over 3 min. BI (n = 21): ropivacaine 0.1% plus fentanyl 2 µg/mL for maintaining epidural analgesia. A rate of 5 mL/h was initiated 1 min after time 0 by using a Terumo syringe pump |
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Outcomes | Rate of breakthrough pain with need for anaesthetic intervention LA consumption per hour |
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Notes | Study dates not stated Funding sources not declared No conflict of interests declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not stated: Quote: "The parturients were then randomly assigned by the blind opaque envelope technique to receive either epidural CIB (n = 21) or CEI (n = 21)" |
Allocation concealment (selection bias) | Low risk | Allocation by sealed opaque envelopes: Quote:"The parturients were then randomly assigned by the blind opaque envelope technique to receive either epidural CIB (n = 21) or CEI (n = 21)" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Epidurals were performed by the principal investigator: Quote:"All blocks performed by the principal investigator (S.M.H.C.)" Blinding of epidural pump settings to participants were not specified. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It was not stated if participants were blinded. Quote:"All data was collected by an anaesthesiologist who was not involved in instituting the block" |
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 | Sample size was computed to detect a 30‐min difference (α = 0.05, ß = 0.2) in the duration of analgesia |