We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01190722
First Posted: August 30, 2010
Last Update Posted: March 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Karolinska Institutet
  Purpose
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).

Condition Intervention Phase
Hallux Valgus Postoperative Pain Drug: etoricoxib Drug: Diclofenac Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

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


Enrollment: 0
Study Start Date: November 2010
Arms Assigned Interventions
Experimental: etoricoxib
active study drug, coxib
Drug: etoricoxib
120 mg once daily for the 1st 6 postoperative days
Active Comparator: diclofenac
active traditional NSAID control
Drug: Diclofenac
50 mg oral 3 times daily the 1st 6 postoperative days

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190722


Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Jan Jakobsson, Professor Karolinska Institutet
  More Information

Responsible Party: Jan Jakobsson, Foot and Ankle Surgical Center
ClinicalTrials.gov Identifier: NCT01190722     History of Changes
Other Study ID Numbers: 201001HV
First Submitted: August 27, 2010
First Posted: August 30, 2010
Last Update Posted: March 31, 2015
Last Verified: July 2010

Keywords provided by Karolinska Institutet:
Day case surgery
postoperative pain
NSAIDs
Coxibs

Additional relevant MeSH terms:
Pain, Postoperative
Hallux Valgus
Bunion
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired
Diclofenac
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors