title: 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.
abstract: 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.
authors.affiliation: Department of Anaesthesiology and Intensive Care Medicine, General Hospital Linz, Austria. hans.gombotz@akh.linz.at
authors.forename: Hans
authors.initials: H
authors.lastname: Gombotz
authors.forename: Regina
authors.initials: R
authors.lastname: Lochner
authors.forename: Rudolf
authors.initials: R
authors.lastname: Sigl
authors.forename: Johann
authors.initials: J
authors.lastname: Blasl
authors.forename: Günther
authors.initials: G
authors.lastname: Herzer
authors.forename: Helmut
authors.initials: H
authors.lastname: Trimmel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D019644:Arthroplasty, Replacement, Hip; D004008:Diclofenac / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009294:Narcotics / Q000008:administration & dosage*; D009966:Orphenadrine / Q000009:adverse effects / Q000627:therapeutic use*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D011446:Prospective Studies
chemical_list: D000700:Analgesics; D004338:Drug Combinations; D009294:Narcotics; C487365:Neodolpasse; D004008:Diclofenac; D009966:Orphenadrine