Effectiveness of Etoricoxib as an Additive Analgesic to Epidural Analgesia in Colon or Rectal Fast-track Surgery

NCT01259830 | Terminated Phase 4

• 1 other identifier: Etoricoxib-fast-track
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 4

Brief Summary

Post-operative pain after laparoscopic colon and rectal surgery in fast-track design. A fast-track program is an evidence-based, multimodal approach for patients undergoing surgery to reduce perioperative morbidity, hospital stay and cost and to increase patient centered well-being. Optimized pain relief is a core component of any fast-track regimen. In this context epidural analgesia has become the standard of care for early postoperative pain therapy. However, it is debated whether non-opioid analgesics should be given as adjuncts when epidural analgesia is already present. The purpose of this study is to demonstrate that the administration of etoricoxib 120mg additionally to the clinical routine therapy (epidural catheter) reduces the post-operative pain level during movement after laparoscopic colon surgery in the fast-track design.

Conditions

Post-operative Pain

Keywords

fast-track; colon or rectal surgery; pain relief

Outcome Measures

Primary Outcomes (1)

• Primary end point of the study is the average pain level (scale 0-10) in the area of surgery during movement (walking a fixed number of steps) under active epidural analgesia, at the third day following laparoscopic colon or rectal surgery.

  To demonstrate that the administration of etoricoxib 120mg additionally to the clinical routine therapy (epidural catheter) reduces the post-operative pain level during movement at the third day after laparoscopic colon or rectal surgery in the fast-track design.

  Third postoperative day

Secondary Outcomes (10)

• Post-operative pain level during movement in the first 2 days after laparoscopic colon or rectal surgery.

  In the first 2 days after laparoscopic colon or rectal surgery

• Post-operative pain level during rest in the first 2 days after laparoscopic colon or rectal surgery.

  In the first 2 days after laparoscopic colon or rectal surgery

• Post-operative pain level during rest and movement from the third (one day after epidural catheter removal) until the fifth day after laparoscopic colon or rectal surgery

  In the first three days after epidural catheter removal

• Incidence of pain events and the average pain intensity in body parts outside of the area of operations.

  In the first three days after epidural catheter removal

• Incidence of new organ dysfunctions

  In the first nine days after laparoscopic colon or rectal surgery

Study Arms (2)

Arcoxia® 120 mg

EXPERIMENTAL

Drug: Arcoxia®120 mg

Sugar pill

PLACEBO COMPARATOR

Drug: P Tablet White Lichtenstein

Interventions

Arcoxia®120 mg DRUG

Arcoxia® over encapsulated 120 mg; Perioperatively 6 days 1 tablet (Arcoxia® 120 mg) for oral use

Also known as: Etoricoxib

Arcoxia® 120 mg

P Tablet White Lichtenstein DRUG

P Tablet White Lichtenstein over encapsulated; Perioperatively 6 days 1 tablet for oral use

Sugar pill

Eligibility Criteria

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

You may qualify if:

• aged 18 or over
• written informed consent
• realization of colon or rectal surgery in the fast track design after clinical standards including an epidural catheter

You may not qualify if:

• ASA status IV-V
• allergy against etoricoxib, other components or other NSAID
• coronary heart disease
• heart insufficiency NYHA II-IV
• cerebrovascular disease
• peripheral arterial occlusive disease
• untreated arterial hypertonus
• active peptic ulcera or active gastrointestinal bleeding
• minor to severe liver dysfunction (beginning from Child - Plugh - Classification A)
• kidney insufficiency
• inflammatory bowel disease
• pregnancy (positive hCG laboratory test) or lactation
• placement in an institution on order of an official authority
• missing consent for saving and passing on pseudonymous data
• hereditary galactose-intolerance, lactase deficit, glucose-galactose-malabsorption

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (4)

St. Hedwig Kliniken Berlin GmbH, Department of Anesthesiology and Intensive Care Medicine

Berlin, State of Berlin, 10115, Germany

Location

Department of Anesthesiology, Sana-Klinikum Lichtenberg, Oskar-Ziethen-Krankenhaus

Berlin, State of Berlin, 10365, Germany

Location

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum/Campus Charité Mitte, Charité Universitätsmedizin

Berlin, State of Berlin, 13353, Germany

Location

Department of Anesthesiology, Johannes Wesling Klinikum Minden Mühlenkreiskliniken (AöR)

Minden, 32429, Germany

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Claudia Spies, MD, Prof.

  Dept. of Anesthesiology and Intensive Care, Charité, Universitätsmedizin Berlin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. MD, Director of the Dept. of Anesthesiology and Intensive Care Medicine, CVK, CCM, Charite University, Berlin, Germany

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 14, 2010
• Study Start: March 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

DE (4)