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. 2018 May 17;2018(5):CD011344. doi: 10.1002/14651858.CD011344.pub2

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
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
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)
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
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.