Total amount: € 0,00
Online ISSN 1827-1596
Casimiro C. 1, Rodrigo J. 2, Mendiola M. A. 3*, Rey F. 4, Barrios A. 1, Gilsanz F. 5** and the Spanish Chirocaine Cooperative Group
1 Medical Department, Abbott Laboratories Spain, Madrid, Spain;
2 Department of Anesthesiology, Fundaciòn Jiménez Diaz, Madrid, Spain;
3 Department of Anesthesiology, Clìnica Femenìa, Palma de Mallorca, Spain;
4 Department of Anesthesiology, Complejo Hospitalario de Vigo, Vigo, Spain;
5 Department of Anesthesiology, La Paz Hospital, Madrid, Spain
*Dr. Mendiola is currently working in Clínica Planas, Palma de Mallorca.
**Dr. Gilsanz started his work on this study at H. La Princesa, and during the course of the trial he moved to H. La Paz, Madrid.
Background. To compare the anaesthetic epidural effects of levobupivacaine plus fentanyl versus bupivacaine plus fentanyl in patients undergoing lower limb surgery.
Methods. A single blind, randomised, prospective, multicentre study was designed to compare both therapies. The study was conducted in 10 tertiary hospitals. A total of 96 patients who were ASA I or II, who required at least a 24-hour-stay in the hospital and who were subjected to surgery of lower limbs with epidural anaesthesia were enrolled in this study. Treatments were administered at a dosage of 1.2 ml per metamera,including a test dose (3 mL) and the dose of fentanyl (100 µg). Patients were then randomly allocated to receive either Levobupivacaine (n = 49) or bupivacaine (N.= 47). The primary endpoint was sensory blockade (SB) duration. Secondary evaluations included motor blockade (MB), post-surgery analgesic medication usage, safety and the investigator global evaluation.
Results. SB duration was similar for both interventions: 195 min (165-205) in the bupivacaine group versus 170 min (140-185) in the levobupivicaine group (log-rank test, P=0.884). However, the lack of MB as evaluated by the modified Bromage scale was significantly higher in the levobupivacaine group than in the bupivacaine group (39% vs 13%, P=0.017). Although no significant differences in MB duration were observed between the groups, a trend was observed in the levobupivacaine group, which had a lesser MB (P=0.093). Investigator satisfaction was high and was assessed to a similar extent for both interventions. Forty-one adverse events were detected in 28 patients, with no differences between groups: 15 (33%) with bupivacaine and 13 (27%) with levobupivacaine, P=0.516.
Conclusion. Although both interventions showed similar anaesthetic effects, a higher proportion of patients receiving levobupivacaine lacked MB.