Etoricoxibe - Preemptive and Postoperative Analgesia for Abdominal and Thoracic Surgery (EPPA)

January 15, 2015 updated by: Dominik Irnich, Ludwig-Maximilians - University of Munich

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Etoricoxib (brand name Arcoxia worldwide; also Algix and Tauxib in Italy) is a new COX-2 selective inhibitor (approx. 106.0 times more selective for COX-2 inhibition over COX-1). Doses are 120 mg/day for acute pain. Current therapeutic indications are: treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, chronic low back pain, acute pain and gout. Note that approved indications differ by country.

Like any other COX-2 selective inhibitor, Etoricoxib selectively inhibits isoform 2 of cyclo-oxigenase enzyme (COX-2). This reduces the generation of prostaglandins (PGs) from arachidonic acid. Among the different functions exerted by PGs, their role in the inflammation cascade should be highlighted. COX-2 selective inhibitor (aka "COXIB") showed less marked activity on type 1 cycloxigenase compared to traditional non-steroidal anti-inflammatory drugs (NSAID). This reduced activity is the cause of reduced gastrointestinal toxicity.

Quantitative sensory tests (QST) are techniques employed to measure the intensity of stimuli needed to produce specific sensory perceptions. They are used to evaluate a sensory detection threshold or other sensory responses from supra-threshold stimulation. The common physical stimuli are (i) touch-pressure, (ii) vibration, and (iii) coolness, warmth, cold pain, and heat pain. In QST, the subject must be able to comprehend what is being asked by the test, alert and not taking mind-altering medications, and not biased to a certain test outcome.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gauting, Germany, 82131
        • Zentrum für Pneumologie und Thoraxchirurgie, Asklepios Fachkliniken München-Gauting
      • München, Germany, 80336
        • Chirurgische Klinik und Poliklinik, Innenstadt, Klinikum der Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Preemptive
Preemptive group patients get Etoricoxibe twice (before and after surgery) or just a single preoperative dose
Drug: Etoricoxibe
Preemptive group patients get Etoricoxibe either twice (before and after surgery) or just a single preoperative dose.
Other Names:
  • Etoricoxibe 120mg Registration-N° 59863.02.00
PLACEBO_COMPARATOR: Postoperative
Postoperative group patients get placebo before surgery and either a drug application or a placebo again after surgery.
Drug: Placebo
Postoperative group patients get placebo before surgery and either a drug application or a placebo again after surgery (so called 2x2 factorial study design).
Other Names:
  • Placebo-Etoricoxibe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative use of morphine as assessed within first 48 hours after surgery
Time Frame: first 48 hours
first 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in patients level of sensibilisation will be measured with help of quantitative sensory testing (a standardised procedure) before and after surgery.
Time Frame: preoperative and 48h postoperative
preoperative and 48h postoperative
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.
Time Frame: 48 hours postoperative
48 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Dominik Irnich, PD. Dr., Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich, Munich, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

July 15, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (ESTIMATE)

July 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPC-UM-0002-DI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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