Etoricoxibe - Preemptive and Postoperative Analgesia for Abdominal and Thoracic Surgery
Status:
Terminated
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
This randomised placebo controlled double-blinded bicentre study (phase III) was designed to
evaluate the preemptive and postoperative analgetic impact of etoricoxibe in open abdominal
and thoracic surgery. Etoricoxib selectively inhibits isoform 2 of cyclo-oxigenase enzyme
(COX-2).
Therefore 120 patients (ASA-risk 1-2) with upcoming abdominal or thoracic surgery should be
included into this study. Patients are randomly allocated to either the preemptive or the
postoperative Etoricoxibe group. These two groups are divided each into two arms. Preemptive
group patients get Etoricoxibe either twice (before and after surgery) or just a single
preoperative dose. Postoperative group patients get placebo before surgery and either a drug
application or a placebo again after surgery (so called 2x2 factorial study design).
Cumulative use of morphine as assessed within first 48 hours after surgery is the primary
trial outcome indicating the analgesic potency of Etoricoxibe.
In addition, changes in patients level of sensibilisation will be measured with help of
quantitative sensory testing (a standardised procedure) before and after surgery (secondary
outcome). In addition pharmacogenetic testing will provide information about genetic
aberrations (so called polymorphisms) of the patients enzymes that should be compared to the
individual reaction regarding Etoricoxibe.
The results will give hint about the analgesic impact of etoricoxibe in acute postoperative
pain. There will be findings for preemptive analgesia and nerval processes. All this could
lead to an improvement of postoperative pain relief while administrating preemptively a COX-2
selective inhibitor before surgery.