Lim 2005.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Setting: recruited from KK Women's and Children's Hospital, Singapore Participants: age 30 ± 6 years (AMB) and 31 ± 5 years (BI) Sample size: N = 60 Inclusion criteria: ASA I nulliparous labouring parturients at term who requested neuraxial analgesia in established labour with cervical dilatation less than or equal to 5 cm and with baseline pain scores more than or equal to 50 (on a 0–100 visual analogue scale (VAS): 0 = no pain, 100 = worst pain imaginable) |
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Interventions | AMB (n = 30): 5 mL epidural boluses of levobupivacaine 0.1% with fentanyl 2 µg/mL every 30 min. This was initiated 15 min after the intrathecal component was given BI (n = 30): levobupivacaine 0.1% with fentanyl 2 µg/mL at a rate of 10 mL/h as a continuous infusion delivered by a syringe pump. The epidural infusion was initiated in the next minute after the intrathecal component was given |
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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 Maternal satisfaction 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 | Randomised using a computer‐generated table: Quote:"The parturients were randomized using a computer generated table into two groups." |
Allocation concealment (selection bias) | High risk | Allocation concealment was not mentioned. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The study was:Quote:"double‐blinded", but did not specifically state if participants and clinical personnel were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of participants were not stated. Outcome assessors were blinded: Quote:"An anesthetist, who was not involved in performing the block and blinded to the mode of drug delivery, collected the following data..." |
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 was computed to detect a 40% reduction of incidence of breakthrough pain |