Status:
TERMINATED
Effectiveness of Etoricoxib as an Additive Analgesic to Epidural Analgesia in Colon or Rectal Fast-track Surgery
Lead Sponsor:
Claudia Spies
Conditions:
Post-operative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 perioper...
Detailed Description
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. Pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01259830
Start Date
March 1 2011
End Date
April 1 2014
Last Update
May 23 2014
Active Locations (4)
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1
St. Hedwig Kliniken Berlin GmbH, Department of Anesthesiology and Intensive Care Medicine
Berlin, State of Berlin, Germany, 10115
2
Department of Anesthesiology, Sana-Klinikum Lichtenberg, Oskar-Ziethen-Krankenhaus
Berlin, State of Berlin, Germany, 10365
3
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum/Campus Charité Mitte, Charité Universitätsmedizin
Berlin, State of Berlin, Germany, 13353
4
Department of Anesthesiology, Johannes Wesling Klinikum Minden Mühlenkreiskliniken (AöR)
Minden, Germany, 32429