Etoricoxibe - Preemptive and Postoperative Analgesia for Abdominal and Thoracic Surgery

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Collaborator: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Programmed abdominal or thoracic surgery

• Patients > 18 yrs

• Patients are aware of German language

• Participation is voluntary

• ASA-risk class 1-2 (American Society of Anesthesiologists guidelines)

Exclusion Criteria:

• Severe cardiac, pulmonary, renal or neurologic disease

• ASA risk III and IV

• Insulin dependent Diabetes mellitus

• Polyneuropathy

• Chronic pain

• Use of analgesic drugs

• Ulcus duodeni

• Ulcus ventriculi

• Time after intestinal bleeding

• Allergy reactions towards coxibes or coxibe-like drugs

• Pregnancy and lactation

• Severe hepatic disease (Albumin < 25 g/l or Child-Pugh-Score ≥ 10)

• Children and Teenager < 16 years

• Chronic intestinal inflammation

• Heart failure (NYHA II - IV)

• Inbalancend arterial hypertension