A comparison of levobupivacaine 0.125%, fentanyl 4 microg/mL, or their combination for patient-controlled epidural analgesia after major orthopedic surgery.

UNLABELLED: Levobupivacaine, the isolated S(-) isomer of bupivacaine, is less cardiotoxic than racemic bupivacaine in animal studies. We studied the effectiveness of patient-controlled epidural analgesia (PCEA) with either levobupivacaine 0.125% or fentanyl 4 microg/mL alone, or a combination of levobupivacaine and fentanyl in 65 patients after total joint arthroplasty in a prospective, random, double-blinded fashion. Intraoperatively, all patients received 20 mL of 0.75% levobupivacaine. Study medication was infused at an initial rate of 4 mL/h, with additional medication available on patient demand (2 mL/10 min). The combination of levobupivacaine and fentanyl produced better analgesia (longer time to first PCEA request; P = 0.007 combination versus fentanyl and P = 0.006 combination versus levobupivacaine) than either drug alone. Patients in the levobupivacaine groups had appreciable sensory blockade to pinprick with minimal motor impairment. Resting and dynamic visual analog scale pain scores were lower in the combination group than in the plain fentanyl group at 6 (P = 0.022 and 0.036) and 12 h (P = 0.002 and 0.001). The 24-h overall patient- and investigator-rated visual analog scale pain scores were also lower in the combination group (resting P = 0.007, dynamic P = 0.005). There was no significant difference among the groups in the incidence of postoperative nausea (26.2%), pruritus (9.2%), hypotension (23.1%), or sedation (0%). We conclude that the analgesic effects of levobupivacaine 0.125% and fentanyl (4 microg/mL) are additive and beneficial for the management of orthopedic surgical pain by the PCEA method. Patients in this study began demand-dosing later, reported lower pain scores, and had no greater risk of adverse events than those who were given either levobupivacaine or fentanyl alone. IMPLICATIONS: We demonstrated a significant additive effect of the combination of levobupivacaine (0.125%) and fentanyl (4 microg/mL), compared with either drug alone, when using patient-controlled epidural analgesia in patients after total joint arthroplasty.

RCT Entities:   Population Interventions Outcomes