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OpenTrials
Completed

NCT Number: NCT00565682

Pain Post Abdominal Laparoscopy Prevention With Arcoxia

To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.

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Key information

Conditions

Laparoscopic Surgery for Appendicitis Laparoscopic Surgery for Cholecystitis Laparoscopic Surgery for Ovarian Cysts

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary acceptance to participate in the study and signed the informed consent form
  • Age older than 18 years old and younger than 70 years
  • Diagnosis of appendicitis, cholecystitis or ovarian cysts suitable of laparoscopic surgery

Exclusion criteria

  • Age less than 18 years or older than 70 years.
  • Laparoscopic procedures for diagnostic purposes.
  • Current use of anticoagulants.
  • Known hypersensitivity to etoricoxib or its components.
  • History of a CABG or MI (less than 1 year)
  • History of unstable angina (over the past six months).
  • Current inflammatory bowel disease.
  • Uncontrolled hypertension or heart failure
  • Renal dysfunction/impairment (creatinine clearance < 30ml/min)
  • Cirrhosis or severe hepatic dysfunction
  • Any degree of dehydration (mild to severe)

Treatment and study plan

Etoricoxib 120 mg

Drug

etoricoxib 120 mg, tablet, orally, OD

Other names: Arcoxia

Primary outcomes

  1. To measure the amount of rescue medication (opioid) needed to relief

    Time frame: Every hour after surgery

Secondary outcomes

  1. To determine the overall analgesic effect using the visual analog scale (VAS)

    Time frame: Every hour after surgery

Sponsors and collaborators

Lead sponsor

Hospital Vozandez

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2006
Study completion
2006
First posted
Nov 30, 2007
Registry last updated
Nov 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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