Fettes 2006.
Study characteristics | ||
Methods | Parallel, randomised controlled trial | |
Participants | Setting: recruited from Ninewells Hospital and Medical School, Dundee, UK Sample size: N = 47 (N completers = 40) Participants: age 25.8 ± 6.3 years (AMB) and 27.1 ± 4.5 years (BI) Inclusion criteria: ASA I–II primigravid participants with uncomplicated, full‐term (> 37 weeks) pregnancy 7 women were excluded after epidural catheter placement: 3 because of inadequate analgesia at 45 min; and 1 each because of patchy block, epidural filter disconnection, catheter occlusion and study protocol violation |
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Interventions | AMB (n = 20): ropivacaine 2 mg/mL with fentanyl 2 mg/mL. Hourly boluses, delivered at 2 mL/min, were started 30 min after time zero BI (n = 20): ropivacaine 2 mg/mL with fentanyl 2 mg/mL. Infusion was started immediately at a constant rate of 10 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 dose Apgar scores |
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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) | Low risk | Randomisation by computer‐generated numbers: Quote:"Patients were then randomized (computer generated numbers inserted into opaque envelopes) to receive either a continuous infusion (control group) or intermittent administration (study group)" |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment by opaque envelopes, but it was not stated if envelopes were sealed: Quote:"Patients were then randomized (computer generated numbers inserted into opaque envelopes) to receive either a continuous infusion (control group) or intermittent administration (study group)" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of participants was not stated. Clinical staff were blinded: Quote:"participants were nursed in the sitting position by staff that were unaware of the treatment used." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of participants was not stated. The outcome assessor was blinded: Quote:"Observations were made by an assessor 'blind' (the pump was covered) to the mode of drug administration" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low attrition; all randomised patients completed the study. |
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 of 40 participants (20 per group) would give the study a power of > 0.9 to detect a statistically significant difference in visual analogue pain scores |