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

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Claudia Spies
• Treatments: Analgesics; Etoricoxib

Criteria

Inclusion Criteria:

• aged 18 or over

• written informed consent

• no inclusion in other medical studies according to the AMG (German drug law) during the study period

• realization of colon or rectal surgery in the fast track design after clinical standards including an epidural catheter

Exclusion Criteria:

• 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

• Women of child-bearing potential who are not using a highly effective contraception method with a pearl-index < 1 during study participation and for at least 3 consecutive months after study inclusion.

• 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

• no correct epidural catheter placement within 48 h after surgery