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CompletedNCT00565682Updated Nov 30, 2007

Pain Post Abdominal Laparoscopy Prevention With Arcoxia

A Phase 4 interventional study of etoricoxib 120 mg in Laparoscopic Surgery for Appendicitis, Laparoscopic Surgery for Cholecystitis and Laparoscopic Surgery for Ovarian Cysts, sponsored by Hospital Vozandez. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-11-30.

Sponsored by Hospital Vozandez · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Laparoscopic Surgery for Appendicitis
  • Laparoscopic Surgery for Cholecystitis
  • Laparoscopic Surgery for Ovarian Cysts
03

In context

Appendicitis

412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.

This study's enrollment of 60 is below the median of 111 across 246 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

This is the only study on the registry with Hospital Vozandez as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    A

    Etoricoxib 120 mg

    Drug: etoricoxib 120 mg

Interventions

  • Drugetoricoxib 120 mg

    etoricoxib 120 mg, tablet, orally, OD

    Also known as: Arcoxia

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00565682
Lead sponsor
Hospital Vozandez
Collaborators
Merck Sharp & Dohme LLC
First posted
Nov 30, 2007
Start date
Apr 2006
Completion
Dec 2006
Last update
Nov 30, 2007

Study contacts

Eduardo Noboa, MD
principal investigator · Hospital Vozandez

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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