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Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial.

Author(s): Gombotz H, Lochner R, Sigl R, Blasl J, Herzer G, Trimmel H.

Affiliation(s): Department of Anaesthesiology and Intensive Care Medicine, General Hospital Linz, Austria. hans.gombotz@akh.linz.at

Publication date & source: 2010, Wien Med Wochenschr. , 160(19-20):526-34

Multimodal pain management combines analgesics to improve analgesia and reduce side effects. This study investigates the fixed combination of diclophenac and orphenadrin (Neodolpasse(®) Infusion Solution) in patients after unilateral total hip arthroplasty (THA). This prospective, randomized, double-blind, placebo-controlled, multi-centre clinical study enrolled 120 patients receiving patient-controlled analgesia (PCA). Isotonic saline was infused as placebo. The primary efficacy goal was defined as reduction of PCA analgesics used over the first 24 h post-surgery. The study used a three-stage group sequential test design with two interim analyses. Analgesia was monitored by visual analogue scale and verbal rating. Infusion of the Neodolpasse(®) Infusion Solution resulted in a significant reduction in the PCA analgesic requirements by approximately 30% (38.7 ± 21.3 mg vs. 55.9 ± 31.1 mg; p = 0.0004) while maintaining adequate analgesia and patient safety. This study demonstrates that Neodolpasse(®) Infusion Solution significantly reduces PCA analgesic requirements without compromising analgesic effectiveness and safety in THA patients.

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