Skip to main content
. 2023 Jun 5;2023(6):CD011344. doi: 10.1002/14651858.CD011344.pub3

Lim 2010.

Study characteristics
Methods Randomised double‐blinded controlled clinical trial
Participants Setting: recruited from KK Women's and Children's Hospital, Singapore
Sample size: N = 51 (N completers = 50)
Participants: age not provided
Inclusion criteria: healthy nulliparous parturients with cephalic presentation at > 36 weeks gestation in early, spontaneous labour (cervical dilation < 5 cm)
1 woman from CEI group excluded as epidural catheter was blocked and re‐sited 2 hours after initiation of CSE
Interventions AMB (n = 25): 2.5 mL epidural boluses of 0.1% ropivacaine with fentanyl 2 µg/mL, infused over a 2‐minute period, every 15 min. The first bolus was given 7.5 min after the intrathecal injection
BI (n = 25): 0.1% ropivacaine with fentanyl 2 µg/mL at 10 mL/hour, delivered by syringe pump and initiated immediately after the intrathecal injection
Outcomes Rate of breakthrough pain with need for anaesthetic intervention
Rate of caesarean delivery
Rate of instrumental delivery
Duration of labour
Time‐weighted consumption of LA
Maternal satisfaction
Apgar scores
Notes Study dates: 18 February to 19 March 2007
Funding sources not declared
No conflict of interests declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The method of randomisation was not stated: Quote:"This was a randomised, double‐blind controlled clinical trial. We allocated the participants to the AIB and CEI groups using a sealed opaque envelope, which was opened after recruitment by the anaesthetist who was to perform the epidural."
Allocation concealment (selection bias) Low risk Allocation concealment via sealed opaque envelopes: Quote:"We allocated the participants to the AIB and CEI groups using a sealed opaque envelope..."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants and clinical team were blinded: Quote:"The parturient was blinded to the group allocation. All baseline data were gathered by the attending nurse/midwife, who was also blinded to participant study group allocation."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcome assessors were blinded: Quote:"The parturient was blinded to the group allocation. All baseline data were gathered by the attending nurse/midwife, who was also blinded to participant study group allocation."
Incomplete outcome data (attrition bias)
All outcomes Low risk Low attrition; 1 participant out of 51 did not complete 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 calculation: sample size was computed to detect a 30% difference in the incidence of breakthrough pain