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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01190722
Enrollment
0
Registered
2010-08-30
Start date
2010-11-10
Completion date
2010-12-12
Last updated
2017-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus, Postoperative Pain

Keywords

Day case surgery, postoperative pain, NSAIDs, Coxibs

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).

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.

Interventions

DRUGetoricoxib

120 mg once daily for the 1st 6 postoperative days

DRUGDiclofenac

50 mg oral 3 times daily the 1st 6 postoperative days

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Patients Global Evaluation of Study Medicationpostoperative day 1-6Patients self-assessment of global satisfaction with pain medication

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026