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

NCT01259830 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2014-05-23

No results posted yet for this study

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

Interventions

DRUG

Arcoxia®120 mg

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

DRUG

P Tablet White Lichtenstein

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

Sponsors & Collaborators

  • Claudia Spies

    lead OTHER

Principal Investigators

  • Claudia Spies, MD, Prof. · Dept. of Anesthesiology and Intensive Care, Charité, Universitätsmedizin Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01259830 on ClinicalTrials.gov