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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01190722
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Actual Duration (Months): 1.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Nov 10, 2010
• Actual Primary Completion Date: Dec 11, 2010
• Actual Study Completion Date: Dec 12, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patients Global Evaluation of Study Medication [postoperative day 1-6]

   Patients self-assessment of global satisfaction with pain medication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Locations

No locations specified.

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Jan Jakobsson, Professor, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jan Jakobsson, Adj. Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT01190722
• Other Study ID Numbers: 201001HV
• First Posted: Aug 30, 2010
• Last Update Posted: Dec 2, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Jan Jakobsson, Adj. Professor, Karolinska Institutet: Day case surgery; postoperative pain; NSAIDs; Coxibs
• Additional relevant MeSH terms: Hallux Valgus; Bunion; Pain, Postoperative; Diclofenac; Etoricoxib

Study Results

No Results Posted as of Dec 2, 2017