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

This study has been withdrawn prior to enrollment.
Information provided by:
Karolinska Institutet Identifier:
First received: August 27, 2010
Last updated: March 30, 2015
Last verified: July 2010
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.

Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01190722

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

Responsible Party: Jan Jakobsson, Foot and Ankle Surgical Center Identifier: NCT01190722     History of Changes
Other Study ID Numbers: 201001HV
Study First Received: August 27, 2010
Last Updated: March 30, 2015

Keywords provided by 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
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 processed this record on September 21, 2017