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 |
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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 |
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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 Time‐weighted consumption of LA Maternal satisfaction Apgar scores |
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Notes | Study dates: 18 February to 19 March 2007 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) | 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 |