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

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. Identifier: NCT01190722
Recruitment Status : Withdrawn (The study site was closed down)
First Posted : August 30, 2010
Last Update Posted : December 2, 2017
Information provided by (Responsible Party):
Jan Jakobsson, Karolinska Institutet

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).

Condition or disease Intervention/treatment Phase
Hallux Valgus Postoperative Pain Drug: etoricoxib Drug: Diclofenac Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Actual Study Start Date : November 10, 2010
Actual Primary Completion Date : December 11, 2010
Actual Study Completion Date : December 12, 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01190722

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

Responsible Party: Jan Jakobsson, Adj. Professor, Karolinska Institutet Identifier: NCT01190722     History of Changes
Other Study ID Numbers: 201001HV
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Keywords provided by Jan Jakobsson, Karolinska Institutet:
Day case surgery
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Hallux Valgus
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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