BACKGROUND AND OBJECTIVES: The aim of this randomized, single blind phase IIIb study was to evaluate the efficacy of 0.5% levobupivacaine versus 0.5% bupivacaine and 0.75% ropivacaine administered as epidural anesthesia and 0.125% levobupivacaine versus 0.125% bupivacaine and 0.2% ropivacaine for postoperative analgesia. The study was designed to test the equivalence of the overall profile of levobupivacaine against bupivacaine and ropivacaine. In addition, parameters of clinical safety were assessed. METHODS: A total of 88 patients undergoing hip surgery at 12 German academic hospitals were randomly assigned to 3 different treatment groups. Criteria for drug evaluation were the required epidural volume and time until onset and offset of sensory and motor block, the quality of postoperative analgesia using a pain visual analogue scale and verbal rating scale, as well as the need for rescue medication based on statistical non-inferiority testing. RESULTS: With respect to onset and offset of sensory and motor blockade, 0.5% levobupivacaine, 0.5% bupivacaine and 0.75% ropivacaine showed clinically significant equivalent profiles for all primary study endpoints. However, the levobupivacaine group showed a higher demand for intraoperative anesthesia. Postoperative analgesia request and pain scales did not differ significantly between groups, but comparatively lower total drug volumes were required in the bupivacaine group. No relevant differences between the trial groups concerning safety parameters were observed. CONCLUSIONS: The efficacy of epidural levobupivacaine for hip surgery and postoperative analgesia is equivalent and shows a comparable clinical profile to bupivacaine and 50-60% higher concentrated ropivacaine. The results of this equivalence study confirm suggestions derived from previous comparative studies.
RCT Entities:
BACKGROUND AND OBJECTIVES: The aim of this randomized, single blind phase IIIb study was to evaluate the efficacy of 0.5% levobupivacaine versus 0.5% bupivacaine and 0.75% ropivacaine administered as epidural anesthesia and 0.125% levobupivacaine versus 0.125% bupivacaine and 0.2% ropivacaine for postoperative analgesia. The study was designed to test the equivalence of the overall profile of levobupivacaine against bupivacaine and ropivacaine. In addition, parameters of clinical safety were assessed. METHODS: A total of 88 patients undergoing hip surgery at 12 German academic hospitals were randomly assigned to 3 different treatment groups. Criteria for drug evaluation were the required epidural volume and time until onset and offset of sensory and motor block, the quality of postoperative analgesia using a pain visual analogue scale and verbal rating scale, as well as the need for rescue medication based on statistical non-inferiority testing. RESULTS: With respect to onset and offset of sensory and motor blockade, 0.5% levobupivacaine, 0.5% bupivacaine and 0.75% ropivacaine showed clinically significant equivalent profiles for all primary study endpoints. However, the levobupivacaine group showed a higher demand for intraoperative anesthesia. Postoperative analgesia request and pain scales did not differ significantly between groups, but comparatively lower total drug volumes were required in the bupivacaine group. No relevant differences between the trial groups concerning safety parameters were observed. CONCLUSIONS: The efficacy of epidural levobupivacaine for hip surgery and postoperative analgesia is equivalent and shows a comparable clinical profile to bupivacaine and 50-60% higher concentrated ropivacaine. The results of this equivalence study confirm suggestions derived from previous comparative studies.