A controlled study to evaluate the effectiveness of etoricoxib as an additive analgesic to epidural analgesia in colon or rectum fast-track surgery

• Conditions: Post-operative pain after laparoscopic colon or rectum surgery in fast-track design; MedDRA version: 14.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2010-021604-16-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-13
• Last Update Posted: 14 July 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

- age >= 18 years
- written informed consent
- no inclusion in other medical studies according to the AMG (German drug law) during the study period
- realization of planned colon or rectum surgery in the fast track design after clinical standards including an epidural catheter
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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
- light to severe liver dysfunction (beginning from Child - Plugh - Classification A)
- kidney insufficiency
- inflammatory bowl disease
- pregnancy 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
- no correct epidural catheter placement within 48 h after surgery

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified