Effectiveness of Etoricoxib as an Additive Analgesic to Epidural Analgesia in Colon or Rectal Fast-track Surgery
Launched by CLAUDIA SPIES · Dec 13, 2010
Trial Information
Current as of May 14, 2025
Terminated
Keywords
ClinConnect Summary
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. Particularly in visceral surgery of the colon it is gaining widespread acceptance (Schwenk 2009). Optimized pain relief is a core component of any fast-track regimen (Kehlet and Wilmore 2008). In this context epidural analgesia has become the standard of care for early postoperative pain therapy (Hasenberg 2009), providing superior pain relief compared to parenteral opioids (Block 2001).
However...
Gender
ALL
Eligibility 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
About Claudia Spies
Claudia Spies is a distinguished clinical trial sponsor dedicated to advancing medical research and improving patient outcomes through innovative study designs and ethical practices. With a strong focus on collaboration and transparency, the organization facilitates the development of cutting-edge therapies across various therapeutic areas. Claudia Spies is committed to upholding the highest standards of regulatory compliance and patient safety while fostering partnerships with researchers, healthcare providers, and stakeholders. Their mission is to contribute significantly to the body of scientific knowledge and enhance the quality of care through rigorous clinical trials that prioritize participant well-being and scientific integrity.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Minden, , Germany
Patients applied
Trial Officials
Claudia Spies, MD, Prof.
Study Director
Dept. of Anesthesiology and Intensive Care, Charité, Universitätsmedizin Berlin
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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