Geoff P Frawley1, Sarah Downie, Grace H Huang. 1. Department of Paediatric Anaesthesia and Pain Management, Royal Children's Hospital, Flemington Road Parkville, Melbourne, Vic., Australia. geoff.frawley@rch.org.au
Abstract
BACKGROUND:Levobupivacaine is the pure S-enantiomer of bupivacaine. Despite obvious benefits in the event of accidental intravascular injection there has been no studies demonstrating a clinically significant benefit to levobupivacaine over racemic bupivacaine for pediatric regional anesthesia. Given the similar pharmacokinetic profiles of both drugs the studies to date have been underpowered to demonstrate what is likely to be a small difference in clinical effectiveness. Our aim was to determine if there are significant differences in the clinical effectiveness of levobupivacaine compared with racemic bupivacaine for caudal anesthesia in children having lower abdominal surgery. A secondary aim was to determine if there are differences in the incidence of postoperative motor blockade between these agents. METHODS:Three hundred and ten children ranging in age from 1 month to 10.75 years in age having lower abdominal surgery were enrolled. Patients were randomized in a double blind manner to receive a caudal block with either 0.25% bupivacaine (n = 152) or 0.25% levobupivacaine (n = 155) to a total volume of 1 ml x kg(-1). Motor blockade (modified Bromage scale) and postoperative pain or distress (FLACC behavioral scale for postoperative pain) were measured at predetermined time points during the subsequent 120 min. RESULTS: There were no significant adverse effects attributable to levobupivacaine. Success rates were defined as a lack of hemodynamic response to first surgical incision and low postoperative pain scores. At a mean duration of 5 min between block completion and first incision success for 1 ml x kg(-1) of 0.25% bupivacaine was 91% and 94% for 0.25% levobupivacaine. Satisfactory postoperative analgesia was present in 98% of patients after bupivacaine caudal anesthesia and 97.5% for levobupivacaine. At 30 min following caudal anesthesia the incidence of postoperative motor block with racemic bupivacaine was 84% and decreased to 7% at 120 min. For levobupivacaine motor block at 30 min postcaudal was present in 85% and decreased to 11% at 120 min. CONCLUSIONS:Levobupivacaine is an effective agent for caudal anesthesia in children at a recommended dose of 2.5 mg x kg(-1). The rapidity of onset was suitable for establishment of surgical anesthesia and postoperative analgesia was achieved in greater than 97.5% of patients. It appears to be of equivalent potency to racemic bupivacaine in children requiring lower abdominal surgery.
RCT Entities:
BACKGROUND:Levobupivacaine is the pure S-enantiomer of bupivacaine. Despite obvious benefits in the event of accidental intravascular injection there has been no studies demonstrating a clinically significant benefit to levobupivacaine over racemic bupivacaine for pediatric regional anesthesia. Given the similar pharmacokinetic profiles of both drugs the studies to date have been underpowered to demonstrate what is likely to be a small difference in clinical effectiveness. Our aim was to determine if there are significant differences in the clinical effectiveness of levobupivacaine compared with racemic bupivacaine for caudal anesthesia in children having lower abdominal surgery. A secondary aim was to determine if there are differences in the incidence of postoperative motor blockade between these agents. METHODS: Three hundred and ten children ranging in age from 1 month to 10.75 years in age having lower abdominal surgery were enrolled. Patients were randomized in a double blind manner to receive a caudal block with either 0.25% bupivacaine (n = 152) or 0.25% levobupivacaine (n = 155) to a total volume of 1 ml x kg(-1). Motor blockade (modified Bromage scale) and postoperative pain or distress (FLACC behavioral scale for postoperative pain) were measured at predetermined time points during the subsequent 120 min. RESULTS: There were no significant adverse effects attributable to levobupivacaine. Success rates were defined as a lack of hemodynamic response to first surgical incision and low postoperative pain scores. At a mean duration of 5 min between block completion and first incision success for 1 ml x kg(-1) of 0.25% bupivacaine was 91% and 94% for 0.25% levobupivacaine. Satisfactory postoperative analgesia was present in 98% of patients after bupivacaine caudal anesthesia and 97.5% for levobupivacaine. At 30 min following caudal anesthesia the incidence of postoperative motor block with racemic bupivacaine was 84% and decreased to 7% at 120 min. For levobupivacaine motor block at 30 min postcaudal was present in 85% and decreased to 11% at 120 min. CONCLUSIONS:Levobupivacaine is an effective agent for caudal anesthesia in children at a recommended dose of 2.5 mg x kg(-1). The rapidity of onset was suitable for establishment of surgical anesthesia and postoperative analgesia was achieved in greater than 97.5% of patients. It appears to be of equivalent potency to racemic bupivacaine in children requiring lower abdominal surgery.