Etoricoxib--preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy--design and protocols.
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.
Fleckenstein
Johannes
J
Department of Anaesthesiology, University of Munich, Munich, Germany.
Kramer
Sybille
S
Offenbächer
Martin
M
Schober
Gabriel
G
Plischke
Herbert
H
Siebeck
Matthias
M
Mussack
Thomas
T
Hatz
Rudolf
R
Lehmeyer
Lukas
L
Lang
Philip M
PM
Heindl
Bernhard
B
Conzen
Peter
P
Irnich
Dominik
D
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
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