Last reviewed · How we verify
A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Effectiveness of Etoricoxib as an Additive Analgesic to Epidural Analgesia in Colon or Rectal Fast-track Surgery
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.
Details
| Lead sponsor | Claudia Spies |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 81 |
| Start date | 2011-03 |
| Completion | 2014-04 |
Conditions
- Post-operative Pain
Interventions
- Arcoxia®120 mg
- P Tablet White Lichtenstein
Primary outcomes
- 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. — Third postoperative day
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.
Countries
Germany