Capogna 2011.
Methods | Prospective randomized double‐blind controlled study | |
Participants | Setting: recruited from Citta di Roma Hospital, Roma, Italy Sample size: N = 150 (N completers = 145) Participants: age 27 ± 5 years (BI) and 29 ± 5 years (AMB) Inclusion criteria: healthy, nulliparous, term women with singleton, vertex pregnancies in spontaneous labour if cervical dilation was < 4 cm and if her baseline pain score, assessed at the peak of the contraction, was > 50 mm on a 100 mm visual analogue pain scale (VAPS) 5 women in the continuous epidural infusion group excluded: 4 reported VAPS > 10 mm 30 min after the epidural injection and one unintentional epidural catheter dislodgement during labour |
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Interventions | AMB (n = 75): 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, beginning 60 min after the administration of the initial epidural loading dose. PCEA pump was programmed to deliver 5 mL patient‐activated boluses of levobupivacaine 0.125% with a lockout interval of 10 min and a per hour maximum volume of 15 mL BI (n = 70): 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL/h, beginning immediately after the administration of the initial epidural loading dose. PCEA pump was programmed to deliver 5 mL patient‐activated boluses of levobupivacaine 0.125% with a lockout interval of 10 min, and a per hour maximum volume of 15 mL |
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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 dose of LA (levobupivacaine) |
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Notes | Study dates: April 2009 to July 2010 Funding sources not declared No conflict of interests declared References to other studies in this review: Fettes 2006; Leo 2010; Lim 2005 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random‐number sequence |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, opaque envelope |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Unblinded researcher set up the 2 epidural pumps according to group allocation. The participants and other study personnel were blinded to group assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All the observations and assessments were performed by a researcher blinded to the mode of drug administration. The infusion pumps were inserted into an opaque, portable bag. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition and exclusions reported; 5 out of 150 participants dropped out; however, this dropout rate is not significant (3%). |
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 of 70 subjects in each group had a power of at least 80% for a 2‐sided Chi2 test of association between maintenance technique and incidence of motor block, with a significance level set to 0.05. |