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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: 2010-11, Wien Med Wochenschr., 160(19-20):526-34. Epub 2010 Oct 8.

Publication type: Multicenter Study; Randomized Controlled Trial

Multimodal pain management combines analgesics to improve analgesia and reduce side effects. This study investigates the fixed combination of diclophenac and orphenadrin (Neodolpasse((R)) 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((R)) 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((R)) Infusion Solution significantly reduces PCA analgesic requirements without compromising analgesic effectiveness and safety in THA patients.

Page last updated: 2011-12-09

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