title: Etoricoxib--preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy--design and protocols.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT00716833.
authors.affiliation: Department of Anaesthesiology, University of Munich, Munich, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Fleckenstein
authors.forename: Sybille
authors.initials: S
authors.lastname: Kramer
authors.forename: Martin
authors.initials: M
authors.lastname: Offenbächer
authors.forename: Gabriel
authors.initials: G
authors.lastname: Schober
authors.forename: Herbert
authors.initials: H
authors.lastname: Plischke
authors.forename: Matthias
authors.initials: M
authors.lastname: Siebeck
authors.forename: Thomas
authors.initials: T
authors.lastname: Mussack
authors.forename: Rudolf
authors.initials: R
authors.lastname: Hatz
authors.forename: Lukas
authors.initials: L
authors.lastname: Lehmeyer
authors.forename: Philip M
authors.initials: PM
authors.lastname: Lang
authors.forename: Bernhard
authors.initials: B
authors.lastname: Heindl
authors.forename: Peter
authors.initials: P
authors.lastname: Conzen
authors.forename: Dominik
authors.initials: D
authors.lastname: Irnich
mesh_terms: D000698:Analgesia / Q000379:methods*; D016058:Analgesia, Patient-Controlled; D000700:Analgesics / Q000008:administration & dosage* / Q000378:metabolism; D001189:Aryl Hydrocarbon Hydroxylases / Q000235:genetics / Q000378:metabolism; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage* / Q000378:metabolism; D065731:Cytochrome P-450 CYP2C19; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000077613:Etoricoxib; D005858:Germany; D006801:Humans; D006930:Hyperalgesia / Q000209:etiology / Q000517:prevention & control; D007813:Laparotomy / Q000009:adverse effects*; D009020:Morphine / Q000008:administration & dosage; D009294:Narcotics / Q000008:administration & dosage; D010147:Pain Measurement; D017288:Pain Threshold / Q000187:drug effects; D010149:Postoperative Pain / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D015990:Placebo Effect; D011110:Polymorphism, Genetic; D011725:Pyridines / Q000008:administration & dosage* / Q000378:metabolism; D012107:Research Design; D013450:Sulfones / Q000008:administration & dosage* / Q000378:metabolism; D013908:Thoracotomy / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D052246:Cyclooxygenase 2 Inhibitors; D009294:Narcotics; D011725:Pyridines; D013450:Sulfones; D009020:Morphine; D001189:Aryl Hydrocarbon Hydroxylases; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19; D000077613:Etoricoxib