Ensayo clínico, randomizado, paralelo, faseIV, de eficacia de levobupivacaína más fentanilo 1 ug/ml. controlado con bupivacaína más fentanilo 1 ug/ml. y ropivacaína más fentanilo 1 ug/ml. en la analgesia epidural del parto.

Abstract

Background and objective: To test the non-inferiority in terms of analgesic effect of levobupivacaine compared to bupivacaine and ropivacaine. Methods: A hundred and two nulliparous parturients who were at the initial stage of labour were enrolled in this randomised, parallel, double-blind clinical trial. They were randomly divided into three groups that received continuous infusion of levobupivacaine 0.125%, bupivacaine 0.125% or ropivacaine 0.2%, all of them with fentanyl 1?g/ml, at 8 ml/h. Supplementary analgesia was provided if visual analogue pain score was ? 4 (0-10 cm) with an epidural bolus of 8 ml of the study solution (levobupivacaine 0.125%, bupivacaine 0.125% or ropivacaine 0.2%). Results: The mean difference at 60 minutes [95%CI] in analgesic effect of levobupivacaine compared to bupivacaine and ropivacaine was 1.86 [0.97;2.74] and 1.82 [0.95;2.68] respectively. In both cases the non-inferiority margin of 1 cm was crossed. Local anaesthetic consumption: median [interquantile range], levobupivacaine 13.48 mg/h [10.6 16.9], bupivacaine 10 mg/h [10 11.5], and ropivacaine 16 mg/h [16 16] (p<0.001). The need for rescue boluses was greater with levobupivacaine than with bupivacaine and ropivacaine (p<0.001). Motor blockade: bupivacaine was greater than levobupivacaine (p = 0.013). There were no differences in motor blockade between levobupivacaine and ropivacaine. There were no differences between the rest of the parameters we analysed between groups. Conclusions: Levobupivacaine did not prove non-inferior in analgesic effect compared to bupivacaine and ropivacaine when using the regimen tested in this study. The consumption of local anaesthetic in mg/h in our study was ropivacaine>levobupivacaine>bupivacaine. Motor blockade was greater with bupivacaine than with levobupivacaine. Keywords: ANAESTHETICS, LOCAL, levobupivacaine, bupivacaine, ropivacaine; ANALGESICS, OPIOID, fentanyl; ANAESTHETIC TECHNIQUES, labour epidural analgesia.