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Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
etoricoxib 120 mg
Sponsored by
Hospital Vozandez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Surgery for Appendicitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A

    Arm Description

    Etoricoxib 120 mg

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 29, 2007
    Last Updated
    November 29, 2007
    Sponsor
    Hospital Vozandez
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00565682
    Brief Title
    Pain Post Abdominal Laparoscopy Prevention With Arcoxia
    Official Title
    Pain Post Abdominal Laparoscopy Prevention With Arcoxia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hospital Vozandez
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Laparoscopic Surgery for Appendicitis, Laparoscopic Surgery for Cholecystitis, Laparoscopic Surgery for Ovarian Cysts

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Etoricoxib 120 mg
    Intervention Type
    Drug
    Intervention Name(s)
    etoricoxib 120 mg
    Other Intervention Name(s)
    Arcoxia
    Intervention Description
    etoricoxib 120 mg, tablet, orally, OD
    Primary Outcome Measure Information:
    Title
    To measure the amount of rescue medication (opioid) needed to relief
    Time Frame
    Every hour after surgery
    Secondary Outcome Measure Information:
    Title
    To determine the overall analgesic effect using the visual analog scale (VAS)
    Time Frame
    Every hour after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eduardo Noboa, MD
    Organizational Affiliation
    Hospital Vozandez
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Pain Post Abdominal Laparoscopy Prevention With Arcoxia

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