MedDataX Logo

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

NCT ID: NCT01190722

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-10

Study Completion Date

2010-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hallux Valgus Postoperative Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Day case surgery postoperative pain NSAIDs Coxibs

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

etoricoxib

active study drug, coxib

Group Type EXPERIMENTAL

etoricoxib

Intervention Type DRUG

120 mg once daily for the 1st 6 postoperative days

diclofenac

active traditional NSAID control

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

etoricoxib

120 mg once daily for the 1st 6 postoperative days

Intervention Type DRUG

Diclofenac

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jan Jakobsson

Adj. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan Jakobsson, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201001HV

Identifier Type: -

Identifier Source: org_study_id