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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore General Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Etoricoxib

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