Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols

Background and Objective: 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.
Design and Methods: 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. Discussion: 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.