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. 2023 Jun 5;2023(6):CD011344. doi: 10.1002/14651858.CD011344.pub3

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
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
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
Notes Study dates not stated
Funding sources not declared
No conflict of interests declared
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