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

Overview

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).

Full Title of Study: “A Randomized Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 11, 2010

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.

Interventions

  • Drug: etoricoxib
    • 120 mg once daily for the 1st 6 postoperative days
  • Drug: Diclofenac
    • 50 mg oral 3 times daily the 1st 6 postoperative days

Arms, Groups and Cohorts

  • Experimental: etoricoxib
    • active study drug, coxib
  • Active Comparator: diclofenac
    • active traditional NSAID control

Clinical Trial Outcome Measures

Primary Measures

  • Patients Global Evaluation of Study Medication
    • Time Frame: postoperative day 1-6
    • Patients self-assessment of global satisfaction with pain medication

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jan Jakobsson, Adj. Professor – Karolinska Institutet
  • Overall Official(s)
    • Jan Jakobsson, Professor, Principal Investigator, Karolinska Institutet

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.