Etoricoxibe - Preemptive and Postoperative Analgesia for Abdominal and Thoracic Surgery

NCT00716833 | Terminated Phase 3 DMC

• 1 other identifier: MPC-UM-0002-DI
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain; Abdominal Surgery; Thoracic Surgery

Keywords

pain; coxibe; preemptive; abdominothoracic; sensibilisation; Analgesia

Outcome Measures

Primary Outcomes (1)

• Cumulative use of morphine as assessed within first 48 hours after surgery

  first 48 hours

Secondary Outcomes (2)

• Changes in patients level of sensibilisation will be measured with help of quantitative sensory testing (a standardised procedure) before and after surgery.

  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.

  48 hours postoperative

Study Arms (2)

Preemptive

ACTIVE COMPARATOR

Preemptive group patients get Etoricoxibe twice (before and after surgery) or just a single preoperative dose

Drug: Etoricoxibe

Postoperative

PLACEBO COMPARATOR

Postoperative group patients get placebo before surgery and either a drug application or a placebo again after surgery.

Drug: Placebo

Interventions

Etoricoxibe DRUG

Preemptive group patients get Etoricoxibe either twice (before and after surgery) or just a single preoperative dose.

Also known as: Etoricoxibe 120mg Registration-N° 59863.02.00

Preemptive

Placebo DRUG

Postoperative group patients get placebo before surgery and either a drug application or a placebo again after surgery (so called 2x2 factorial study design).

Also known as: Placebo-Etoricoxibe

Postoperative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Zentrum für Pneumologie und Thoraxchirurgie, Asklepios Fachkliniken München-Gauting

Gauting, 82131, Germany

Location

Chirurgische Klinik und Poliklinik, Innenstadt, Klinikum der Universität München

München, 80336, Germany

Location

Related Publications (2)

• Fleckenstein J, Kramer S, Offenbacher M, Schober G, Plischke H, Siebeck M, Mussack T, Hatz R, Lehmeyer L, Lang PM, Heindl B, Conzen P, Irnich D. Etoricoxib--preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy--design and protocols. Trials. 2010 May 27;11:66. doi: 10.1186/1745-6215-11-66.

  PMID: 20504378 BACKGROUND

• Fleckenstein J, Kohls N, Evtouchenko E, Lehmeyer L, Kramer S, Lang PM, Siebeck M, Mussack T, Hatz R, Heindl B, Conzen P, Rehm M, Czerner S, Zwissler B, Irnich D. No effect of the cyclooxygenase-2 inhibitor etoricoxib on pre-emptive and post-operative analgesia in visceral surgery: results of a randomized controlled trial. Eur J Pain. 2016 Feb;20(2):186-95. doi: 10.1002/ejp.699. Epub 2015 Mar 31.

  PMID: 25828692 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Dominik Irnich, PD. Dr.

  Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich, Munich, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Dominik Irnich

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 16, 2008
• Study Start: February 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: January 16, 2015

Record last verified: 2015-01

Locations

DE (2)