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Published in: Trials 1/2010

Open Access 01-12-2010 | Study protocol

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

Authors: Johannes Fleckenstein, Sybille Kramer, Martin Offenbächer, Gabriel Schober, Herbert Plischke, Matthias Siebeck, Thomas Mussack, Rudolf Hatz, Lukas Lehmeyer, Philip M Lang, Bernhard Heindl, Peter Conzen, Dominik Irnich

Published in: Trials | Issue 1/2010

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Abstract

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 × 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 × 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.

Trial registration

NCT00716833
Appendix
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Metadata
Title
Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols
Authors
Johannes Fleckenstein
Sybille Kramer
Martin Offenbächer
Gabriel Schober
Herbert Plischke
Matthias Siebeck
Thomas Mussack
Rudolf Hatz
Lukas Lehmeyer
Philip M Lang
Bernhard Heindl
Peter Conzen
Dominik Irnich
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Trials / Issue 1/2010
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-11-66

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