search
Back to results

A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

Primary Purpose

Hallux Valgus, Postoperative Pain

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
etoricoxib
Diclofenac
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring Day case surgery, postoperative pain, NSAIDs, Coxibs

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiology (ASA) physiological class 1-2 patients
  • aged 18-65 years
  • scheduled for elective hallux valgus surgery in general anesthesia

Exclusion Criteria:

  • NSAID allergy
  • liver disease
  • renal disease
  • uncontrolled cardiovascular disease
  • Lithium therapy
  • chronic pain
  • regular analgesia use

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    etoricoxib

    diclofenac

    Arm Description

    active study drug, coxib

    active traditional NSAID control

    Outcomes

    Primary Outcome Measures

    Patients Global Evaluation of Study Medication
    Patients self-assessment of global satisfaction with pain medication

    Secondary Outcome Measures

    Full Information

    First Posted
    August 27, 2010
    Last Updated
    November 29, 2017
    Sponsor
    Karolinska Institutet
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01190722
    Brief Title
    A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain
    Official Title
    A Randomized Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study site was closed down
    Study Start Date
    November 10, 2010 (Actual)
    Primary Completion Date
    December 11, 2010 (Actual)
    Study Completion Date
    December 12, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs).
    Detailed Description
    The aim of the present study is to compare patients' satisfaction with pain medication during the first 7 first postoperative days following elective hallux valgus surgery in general anaesthesia between etoricoxib and diclofenac in a prospective randomised double-blind study design.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hallux Valgus, Postoperative Pain
    Keywords
    Day case surgery, postoperative pain, NSAIDs, Coxibs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    etoricoxib
    Arm Type
    Experimental
    Arm Description
    active study drug, coxib
    Arm Title
    diclofenac
    Arm Type
    Active Comparator
    Arm Description
    active traditional NSAID control
    Intervention Type
    Drug
    Intervention Name(s)
    etoricoxib
    Intervention Description
    120 mg once daily for the 1st 6 postoperative days
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac
    Intervention Description
    50 mg oral 3 times daily the 1st 6 postoperative days
    Primary Outcome Measure Information:
    Title
    Patients Global Evaluation of Study Medication
    Description
    Patients self-assessment of global satisfaction with pain medication
    Time Frame
    postoperative day 1-6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiology (ASA) physiological class 1-2 patients aged 18-65 years scheduled for elective hallux valgus surgery in general anesthesia Exclusion Criteria: NSAID allergy liver disease renal disease uncontrolled cardiovascular disease Lithium therapy chronic pain regular analgesia use
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan Jakobsson, Professor
    Organizational Affiliation
    Karolinska Institutet
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

    We'll reach out to this number within 24 hrs