Cargando…

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 laparot...

Descripción completa

Detalles Bibliográficos
Autores principales: Fleckenstein, Johannes, Kramer, Sybille, Offenbächer, Martin, Schober, Gabriel, Plischke, Herbert, Siebeck, Matthias, Mussack, Thomas, Hatz, Rudolf, Lehmeyer, Lukas, Lang, Philip M, Heindl, Bernhard, Conzen, Peter, Irnich, Dominik
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2890651/
https://www.ncbi.nlm.nih.gov/pubmed/20504378
http://dx.doi.org/10.1186/1745-6215-11-66
_version_ 1782182827119345664
author Fleckenstein, Johannes
Kramer, Sybille
Offenbächer, Martin
Schober, Gabriel
Plischke, Herbert
Siebeck, Matthias
Mussack, Thomas
Hatz, Rudolf
Lehmeyer, Lukas
Lang, Philip M
Heindl, Bernhard
Conzen, Peter
Irnich, Dominik
author_facet Fleckenstein, Johannes
Kramer, Sybille
Offenbächer, Martin
Schober, Gabriel
Plischke, Herbert
Siebeck, Matthias
Mussack, Thomas
Hatz, Rudolf
Lehmeyer, Lukas
Lang, Philip M
Heindl, Bernhard
Conzen, Peter
Irnich, Dominik
author_sort Fleckenstein, Johannes
collection PubMed
description 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
format Text
id pubmed-2890651
institution National Center for Biotechnology Information
language English
publishDate 2010
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-28906512010-06-24 Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols Fleckenstein, Johannes Kramer, Sybille Offenbächer, Martin Schober, Gabriel Plischke, Herbert Siebeck, Matthias Mussack, Thomas Hatz, Rudolf Lehmeyer, Lukas Lang, Philip M Heindl, Bernhard Conzen, Peter Irnich, Dominik Trials Study protocol 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 BioMed Central 2010-05-27 /pmc/articles/PMC2890651/ /pubmed/20504378 http://dx.doi.org/10.1186/1745-6215-11-66 Text en Copyright ©2010 Fleckenstein et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study protocol
Fleckenstein, Johannes
Kramer, Sybille
Offenbächer, Martin
Schober, Gabriel
Plischke, Herbert
Siebeck, Matthias
Mussack, Thomas
Hatz, Rudolf
Lehmeyer, Lukas
Lang, Philip M
Heindl, Bernhard
Conzen, Peter
Irnich, Dominik
Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols
title Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols
title_full Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols
title_fullStr Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols
title_full_unstemmed Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols
title_short Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols
title_sort etoricoxib - preemptive and postoperative analgesia (eppa) in patients with laparotomy or thoracotomy - design and protocols
topic Study protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2890651/
https://www.ncbi.nlm.nih.gov/pubmed/20504378
http://dx.doi.org/10.1186/1745-6215-11-66
work_keys_str_mv AT fleckensteinjohannes etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT kramersybille etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT offenbachermartin etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT schobergabriel etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT plischkeherbert etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT siebeckmatthias etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT mussackthomas etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT hatzrudolf etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT lehmeyerlukas etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT langphilipm etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT heindlbernhard etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT conzenpeter etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols
AT irnichdominik etoricoxibpreemptiveandpostoperativeanalgesiaeppainpatientswithlaparotomyorthoracotomydesignandprotocols