Efficacy Study of Pre-emptive Etoricoxib for Postoperative Pain and Functional Outcome in Total Knee Arthroplasty

February 8, 2017 updated by: Singapore General Hospital

A Randomized Controlled Trial to Study the Efficacy of Pre-emptive Etoricoxib in Reducing Postoperative Pain and Improving Functional Outcome in Total Knee Arthroplasty

The purpose of this study is to study the efficacy of pre-emptive etoricoxib in reducing post-operative pain and improving function outcome after a total knee arthroplasty.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Total knee arthroplasty (TKA) is one of the most commonly performed orthopaedic surgeries worldwide and has proven to be a success in the treatment of end-stage osteoarthritic knees. TKA is associated with significant postoperative pain which may delay the patient's functional recovery and necessitate an increased use of opioid analgesias, which are themselves associated with significant adverse effects such as nausea and vomiting. The selective cycloxygenase (COX)-2 inhibitor rofecoxib was previously shown in a clinical trial in a paper by Buvanendran et al to reduce postoperative opioid requirement and improve clinical outcomes. Feng et al studied the use of a single dose of rofecoxib pre-operatively and its effect on inflammatory markers and postoperative pain. Rofecoxib has, however, been withdrawn from the market due to its association with cardiovascular side effects. Our current clinical practice in post-operative pain management constitutes post-operative etoricoxib but we hypothesize that pre-emptively administering etoricoxib pre-operatively would give an even greater benefit in terms of post-operative opioid usage, pain scores, and functional recovery in the first 2-3 days. To date, there has been no study investigating etoricoxib as a pre-emptive medication in patients undergoing total knee arthroplasty. We aim to conduct a study to test the efficacy of pre-emptive etoricoxib in reducing postoperative pain, opioid requirement and improving the rate of functional recovery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between the ages of 50 and 80 who are listed for single-knee TKA at Singapore General Hospital by one of 4 adult reconstructive surgeons for the treatment of osteoarthritis will be recruited upon the patient giving written informed consent.

Exclusion Criteria:

  • - Younger than 50, older than 80
  • Known allergy to etoricoxib or other cycloxygenase-2 inhibitors, aspirin or any Non-steroidal Anti-inflammatory Drugs (NSAIDs)
  • American Society of Anaesthesiologists (ASA) grade IV
  • Renal insufficiency (Creatinine > 110)
  • Known coagulation or hepatic disorder
  • Inflammatory arthritis
  • Inflammatory bowel disease
  • Concurrent conditions which would affect interpretation of pain eg spinal stenosis, lumbar nerve root impingement
  • Depression or usage of opioids, sedatives or hypnotics preoperatively
  • Special classes of subjects including those pregnant, cognitively impaired, prisoners or institutionalized patients
  • Patients with clinically significant abnormalities of laboratory safety tests at baseline, or a history of significant clinical or laboratory abnormality that in the opinion of the investigator would contraindicate the use of etoricoxib
  • Patients with unstable hypertension, uncontrolled diabetes mellitus, New York Heart Association (NYHA) class II-IV congestive heart failure, ischaemic heart disease, cerebrovascular disease or peripheral vascular disease (including patients who have recently undergone coronary artery bypass graft of angioplasty)
  • Patients with active gastric ulceration or gastrointestinal bleeding
  • Patients with a history of any illness that in the opinion of the investigator may confound the results of the study or pose additional risks to the patient
  • Occurrence of any surgical complication would exclude the patient from analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
Given placebo tablets preoperatively
Drug: Control
Given placebo
Active Comparator: Etoricoxib
Given etoricoxib preoperatively
Drug: Etoricoxib
Given etoricoxib 120mg 24 hours preoperatively and 120mg 2 hours preoperatively

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Postoperative pain
Time Frame: Within first 5 days after operation
Within first 5 days after operation
Functional recovery postoperatively
Time Frame: Within first 5 days after operation
Within first 5 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Singapore General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shi-lu Chia, MBBS, Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACL-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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