BACKGROUND:Ropivacaine is a new local anaesthetic drug known to be less cardiotoxic than bupivacaine. The aims of this comparative study with bupivacaine were to evaluate efficacy, safety and tolerability for the mother and the neonate when using ropivacaine 7.5 mg/ml for epidural anaesthesia for elective Caesarean section. METHODS: In a double-blind, multicentre trial the patients were randomised to receive 20 ml of either ropivacaine 7.5 mg/ml or bupivacaine 5 mg/ml. The quality of the peroperative analgesia and abdominal muscle relaxation as well as tolerability and safety in both the mother and the neonate were evaluated. RESULTS: A total of 122 patients were evaluated for efficacy and tolerability. There were no significant differences in the onset time and the extent of the sensory spread or motor block. The peroperative quality of anaesthesia and muscle relaxation was similar in both groups. No significant side effects were observed, except for a more profound drop in systolic blood pressure in the ropivacaine group. The anaesthetics were well tolerated by the neonate in both groups, evaluated by Apgar and NACS scores. CONCLUSION:Ropivacaine 7.5 mg/ml administered epidurally resulted in equally effective anaesthesia for Caesarean section as bupivacaine 5 mg/ml. Because of the lower cardiotoxicity of ropivacaine, the new amide has a potential in replacing bupivacaine when used epidurally for Caesarean section.
RCT Entities:
BACKGROUND:Ropivacaine is a new local anaesthetic drug known to be less cardiotoxic than bupivacaine. The aims of this comparative study with bupivacaine were to evaluate efficacy, safety and tolerability for the mother and the neonate when using ropivacaine 7.5 mg/ml for epidural anaesthesia for elective Caesarean section. METHODS: In a double-blind, multicentre trial the patients were randomised to receive 20 ml of either ropivacaine 7.5 mg/ml or bupivacaine 5 mg/ml. The quality of the peroperative analgesia and abdominal muscle relaxation as well as tolerability and safety in both the mother and the neonate were evaluated. RESULTS: A total of 122 patients were evaluated for efficacy and tolerability. There were no significant differences in the onset time and the extent of the sensory spread or motor block. The peroperative quality of anaesthesia and muscle relaxation was similar in both groups. No significant side effects were observed, except for a more profound drop in systolic blood pressure in the ropivacaine group. The anaesthetics were well tolerated by the neonate in both groups, evaluated by Apgar and NACS scores. CONCLUSION:Ropivacaine 7.5 mg/ml administered epidurally resulted in equally effective anaesthesia for Caesarean section as bupivacaine 5 mg/ml. Because of the lower cardiotoxicity of ropivacaine, the new amide has a potential in replacing bupivacaine when used epidurally for Caesarean section.