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

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)
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
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
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 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