title: Levobupivacaine plus fentanyl versus racemic bupivacaine plus fentanyl in epidural anaesthesia for lower limb surgery.
abstract: 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 mg). 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.
  
  
  CONCLUSIONS
  Although both interventions showed similar anaesthetic effects, a higher proportion of patients receiving levobupivacaine lacked MB.
authors.affiliation: Medical Department, Abbott Laboratories Spain, Madrid, Spain. cesar.casimiro@abbott.com
authors.forename: C
authors.initials: C
authors.lastname: Casimiro
authors.forename: J
authors.initials: J
authors.lastname: Rodrigo
authors.forename: M A
authors.initials: MA
authors.lastname: Mendiola
authors.forename: F
authors.initials: F
authors.lastname: Rey
authors.forename: A
authors.initials: A
authors.lastname: Barrios
authors.forename: F
authors.initials: F
authors.lastname: Gilsanz
mesh_terms: D000767:Anesthesia, Epidural; D019162:Anesthetics, Combined / Q000008:administration & dosage*; D000779:Anesthetics, Local / Q000008:administration & dosage*; D002045:Bupivacaine / Q000008:administration & dosage* / Q000031:analogs & derivatives; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage*; D006801:Humans; D007866:Leg / Q000601:surgery*; D000077554:Levobupivacaine; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method
chemical_list: D019162:Anesthetics, Combined; D000779:Anesthetics, Local; D000077554:Levobupivacaine; D005283:Fentanyl; D002045:Bupivacaine