Back to resultsEfficacy Study of Pre-emptive Etoricoxib for Postoperative Pain and Functional Outcome in Total Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Control
Etoricoxib
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- Singapore General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Etoricoxib
Arm Description
Given placebo tablets preoperatively
Given etoricoxib preoperatively
Outcomes
Primary Outcome Measures
Postoperative pain
Functional recovery postoperatively
Secondary Outcome Measures
Full Information
NCT ID
NCT01246362
First Posted
November 21, 2010
Last Updated
February 8, 2017
Sponsor
Singapore General Hospital
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01246362
Brief Title
Efficacy Study of Pre-emptive Etoricoxib for Postoperative Pain and Functional Outcome in Total Knee Arthroplasty
Official Title
A Randomized Controlled Trial to Study the Efficacy of Pre-emptive Etoricoxib in Reducing Postoperative Pain and Improving Functional Outcome in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Given placebo tablets preoperatively
Arm Title
Etoricoxib
Arm Type
Active Comparator
Arm Description
Given etoricoxib preoperatively
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
Given placebo
Intervention Type
Drug
Intervention Name(s)
Etoricoxib
Intervention Description
Given etoricoxib 120mg 24 hours preoperatively and 120mg 2 hours preoperatively
Primary Outcome Measure Information:
Title
Postoperative pain
Time Frame
Within first 5 days after operation
Title
Functional recovery postoperatively
Time Frame
Within first 5 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi-lu Chia, MBBS
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Pre-emptive Etoricoxib for Postoperative Pain and Functional Outcome in Total Knee Arthroplasty
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