BACKGROUND:Levobupivacaine is the S(-)-enantiomer of the racemic bupivacaine. Data of pharmacological studies suggest that levobupivacaine has a lower potential of toxicity for central nervous and cardiovascular systems than does bupivacaine. The present study was undertaken to compare the safety and efficacy between levobupivacaine and bupivacaine in epidural anesthesia for Cesarean delivery. METHODS: A prospective, controlled, double-blinded study was conducted in 45 ASA class I-II Taiwanese obstetric patients undergoing elective Caesarean Section under extradural anesthesia. Patients were randomized to receive either 25 ml of 0.5% bupivacaine or 0.5% levobupivacaine in a double-blinded fashion. The end points of measurements relevant to efficacy included onset, fade-out, and quality of anesthesia. The safety end-point measurements included Apgar scores, maternal ECG, maternal and neonatal blood pH, and adverse events. RESULTS: There was no significant difference between groups in the profile of sensory and motor blockade produced. Comparison of visual analogue pain scores did not show significant differences between groups at the corresponding times. There were no significant differences between groups in muscle relaxation scores assessed by obstetricians as well as the overall assessment of block quality rated by anesthesiologists. Apgar scores, maternal and neonatal blood pH, maternal ECG, and adverse events did not differ between groups. The drug-related adverse events were hypotension and shivering which were equally seen in levobupivacaine and bupivacaine groups. There was no other serious adverse event that happened in both groups. CONCLUSIONS: The onset and fade-out of sensory and motor blockade, quality of anesthesia, muscle relaxation and overall quality of anesthesia as assessed were comparable between two groups. No significant maternal or neonatal adverse events were found between the treatment groups. In comparison, levobupivacaine had the efficacy and safety profile equivalent to bupivacaine in epidural anesthesia for Caesarean section.
RCT Entities:
BACKGROUND:Levobupivacaine is the S(-)-enantiomer of the racemic bupivacaine. Data of pharmacological studies suggest that levobupivacaine has a lower potential of toxicity for central nervous and cardiovascular systems than does bupivacaine. The present study was undertaken to compare the safety and efficacy between levobupivacaine and bupivacaine in epidural anesthesia for Cesarean delivery. METHODS: A prospective, controlled, double-blinded study was conducted in 45 ASA class I-II Taiwanese obstetric patients undergoing elective Caesarean Section under extradural anesthesia. Patients were randomized to receive either 25 ml of 0.5% bupivacaine or 0.5% levobupivacaine in a double-blinded fashion. The end points of measurements relevant to efficacy included onset, fade-out, and quality of anesthesia. The safety end-point measurements included Apgar scores, maternal ECG, maternal and neonatal blood pH, and adverse events. RESULTS: There was no significant difference between groups in the profile of sensory and motor blockade produced. Comparison of visual analogue pain scores did not show significant differences between groups at the corresponding times. There were no significant differences between groups in muscle relaxation scores assessed by obstetricians as well as the overall assessment of block quality rated by anesthesiologists. Apgar scores, maternal and neonatal blood pH, maternal ECG, and adverse events did not differ between groups. The drug-related adverse events were hypotension and shivering which were equally seen in levobupivacaine and bupivacaine groups. There was no other serious adverse event that happened in both groups. CONCLUSIONS: The onset and fade-out of sensory and motor blockade, quality of anesthesia, muscle relaxation and overall quality of anesthesia as assessed were comparable between two groups. No significant maternal or neonatal adverse events were found between the treatment groups. In comparison, levobupivacaine had the efficacy and safety profile equivalent to bupivacaine in epidural anesthesia for Caesarean section.