Gombotz Hans, Lochner Regina, Sigl Rudolf, Blasl Johann, Herzer Günther, Trimmel Helmut
Department of Anaesthesiology and Intensive Care Medicine, General Hospital Linz, Austria.
Wien Med Wochenschr. 2010 Nov;160(19-20):526-34. doi: 10.1007/s10354-010-0829-7. Epub 2010 Oct 8.
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.
多模式疼痛管理联合使用镇痛药以增强镇痛效果并减少副作用。本研究调查双氯芬酸与奥芬那君的固定组合制剂（Neodolpasse® 输液溶液）用于单侧全髋关节置换术（THA）患者的情况。这项前瞻性、随机、双盲、安慰剂对照、多中心临床研究纳入了120例接受患者自控镇痛（PCA）的患者。输注等渗盐水作为安慰剂。主要疗效目标定义为术后24小时内PCA镇痛药使用量的减少。该研究采用三阶段成组序贯试验设计并进行两次中期分析。通过视觉模拟评分法和语言评分法监测镇痛效果。输注Neodolpasse® 输液溶液可使PCA镇痛药需求量显著减少约30%（38.7±21.3毫克对55.9±31.1毫克；p = 0.0004），同时保持充分的镇痛效果和患者安全。本研究表明，Neodolpasse® 输液溶液可显著降低THA患者的PCA镇痛药需求量，且不影响镇痛效果和安全性。
