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

NCT01246362 | Completed Phase 2

• 1 other identifier: ACL-3
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  Within first 5 days after operation

• Functional recovery postoperatively

  Within first 5 days after operation

Study Arms (2)

Control

PLACEBO COMPARATOR

Given placebo tablets preoperatively

Drug: Control

Etoricoxib

ACTIVE COMPARATOR

Given etoricoxib preoperatively

Drug: Etoricoxib

Interventions

Control DRUG

Given placebo

Control

Etoricoxib DRUG

Given etoricoxib 120mg 24 hours preoperatively and 120mg 2 hours preoperatively

Etoricoxib

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shi-lu Chia, MBBS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2010
• First Posted: November 23, 2010
• Study Start: July 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

SG (1)