Randomized, double-blind, phase III, controlled trial comparing levobupivacaine 0.25%, ropivacaine 0.25% and bupivacaine 0.25% by the caudal route in children

Background. The rationale for replacing racemic bupivacaine with the s-enantiomers levobupivacaine and ropivacaine is to provide a wider margin of safety with the same analgesic efficacy and less postoperative motor block. In a randomized, double-blind, phase III, controlled trial we compared the caudal administration of levobupivacaine 0.25% and ropivacaine 0.25% with bupivacaine 0.25% in children. Methods. Ninety-nine ASA I-II children less than 10 yr old scheduled for elective sub-umbilical surgery were randomized to receive caudal block with bupivacaine 0.25%, ropivacaine 0.25% or levobupivacaine 0.25%. The primary outcome of the study was the clinical efficacy of the caudal block during the operation. Secondary outcome measures were analgesic onset time, pain relief after the operation and residual motor blockade. Results. The proportion of children with effective analgesia during the operation was similar among groups. There were no significant differences in the analgesic onset time of the caudal block. Bupivacaine produced a significant incidence of residual motor block compared with levobupivacaine or ropivacaine at wake-up (P<0.01). There were no significant differences in the number of patients receiving rescue analgesia after surgery. However, analgesic block lasted significantly longer in patients receiving bupivacaine (P=0.03). Conclusion. During sub-umbilical surgery, caudal levobupivacaine, ropivacaine and bupivacaine provided comparable analgesic efficacy. Bupivacaine produced a higher incidence of residual motor blockade and a longer analgesic block than ropivacaine and levobupivacaine.