Zusammenfassung
Die multimodale Analgesie kombiniert unterschiedliche Analgetika, um die Wirksamkeit zu steigern und Nebenwirkungen zu verringern. Diese Studie untersuchte die Fixkombination von Diclofenac und Orphenadrin (Neodolpasse® Infusionslösung) an Patienten nach einer einseitigen Hüftarthroplastik (THA). Diese prospektive, randomisierte, doppelblinde, Plazebo-kontrollierte, multizentrische klinische Studie untersuchte 120 Patienten, welche postoperativ eine Patienten kontrollierten Analgesie (PCA) erhielten. Hauptzielparameter war die analgetische Wirksamkeit der Neodolpasse® Infusionslösung gemessen an der Einsparung der PCA-Analgetikums innerhalb der ersten 24 Stunden nach THA. Die Studie wurde in einem sequentiellen 3-stufigen Design mit 2 Interimsanalysen durchgeführt. Die Wirksamkeit der Schmerzbehandlung wurde mit Hilfe einer visuellen Analogskala (VAS) und einer verbalen Beurteilung sichergestellt. Die Infusion der Neodolpasse® Infusionslösung bewirkte bei gleicher analgetischer Wirkung eine signifikante Reduktion des PCA-Analgetikums-Verbrauchs von etwa 30 % (38,7 ± 21,3 mg vs. 55,9 ± 31,1 mg; p = 0,0004). Neodolpasse® Infusionslösung senkt postoperativ den PCA-Morphinverbrauch signifikant ohne negative Effekte auf Analgesie und Patientensicherheit.
Summary
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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Gombotz, H., Lochner, R., Sigl, R. et al. 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. Wien Med Wochenschr 160, 526–534 (2010). https://doi.org/10.1007/s10354-010-0829-7
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DOI: https://doi.org/10.1007/s10354-010-0829-7
Schlüsselwörter
- Postoperative Schmerzbehandlung
- Patienten-kontrollierte Analgesie
- Diclofenac
- Orphenadrin
- Morphin-einsparender Effekt