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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01190722
First received: August 27, 2010
Last updated: June 21, 2011
Last verified: July 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Patients self-assessment of global satisfaction with pain medication


Estimated Enrollment: 200
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190722

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

No publications provided

Responsible Party: Jan Jakobsson, Foot and Ankle Surgical Center
ClinicalTrials.gov Identifier: NCT01190722     History of Changes
Other Study ID Numbers: 201001HV
Study First Received: August 27, 2010
Last Updated: June 21, 2011
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on July 29, 2014