Department of Anaesthesiology, University of Munich, Munich, Germany.
Trials. 2010 May 27;11:66. doi: 10.1186/1745-6215-11-66.
Our objective was to report on the design and essentials of the Etoricoxib protocol- Preemptive and Postoperative Analgesia (EPPA) Trial, investigating whether preemptive analgesia with cox-2 inhibitors is more efficacious than placebo in patients who receive either laparotomy or thoracotomy.
The study is a 2 x 2 factorial armed, double blinded, bicentric, randomised placebo-controlled trial comparing (a) etoricoxib and (b) placebo in a pre- and postoperative setting. The total observation period is 6 months. According to a power analysis, 120 patients scheduled for abdominal or thoracic surgery will randomly be allocated to either the preemptive or the postoperative treatment group. These two groups are each divided into two arms. Preemptive group patients receive etoricoxib prior to surgery and either etoricoxib again or placebo postoperatively. Postoperative group patients receive placebo prior to surgery and either placebo again or etoricoxib after surgery (2 x 2 factorial study design). The Main Outcome Measure is the cumulative use of morphine within the first 48 hours after surgery (measured by patient controlled analgesia PCA). Secondary outcome parameters include a broad range of tests including sensoric perception and genetic polymorphisms.
The results of this study will provide information on the analgesic effectiveness of etoricoxib in preemptive analgesia and will give hints on possible preventive effects of persistent pain.
NCT00716833.
我们的目的是报告依托考昔方案-预防性和术后镇痛（EPPA）试验的设计和要点，研究在接受剖腹术或开胸术的患者中，使用 COX-2 抑制剂进行预防性镇痛是否比安慰剂更有效。
本研究是一项 2 x 2 析因、双盲、双中心、随机安慰剂对照试验，比较（a）依托考昔和（b）安慰剂在术前和术后的应用。总观察期为 6 个月。根据功效分析，将 120 例计划接受腹部或胸部手术的患者随机分配至预防性或术后治疗组。这两组又各分为两组。预防性组患者在术前接受依托考昔，并在术后再次接受依托考昔或安慰剂。术后组患者在术前接受安慰剂，并在术后再次接受安慰剂或依托考昔（2 x 2 析因设计）。主要观察指标是术后 48 小时内吗啡的累积用量（通过患者自控镇痛 PCA 测量）。次要观察指标包括一系列广泛的测试，包括感觉知觉和遗传多态性。
该研究的结果将提供依托考昔在预防性镇痛中镇痛效果的信息，并提示持续性疼痛的可能预防效果。
NCT00716833。
