Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Phase 4

Completed

• Conditions: Laparoscopic Surgery for Appendicitis; Laparoscopic Surgery for Cholecystitis; Laparoscopic Surgery for Ovarian Cysts
• Interventions: Drug: etoricoxib 120 mg

• Registration Number: NCT00565682
• Lead Sponsor: Hospital Vozandez

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study Completion: 2006-12
• Status Verified: 2007-11
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-29
• Last Update Submitted: 2007-11-29
• Study First Posted: 2007-11-30
• Last Update Posted: 2007-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	etoricoxib 120 mg	Etoricoxib 120 mg

Primary Outcome Measures

Name	Time	Method
To measure the amount of rescue medication (opioid) needed to relief	Every hour after surgery

Secondary Outcome Measures

Name	Time	Method
To determine the overall analgesic effect using the visual analog scale (VAS)	Every hour after surgery