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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ang Chia Liang, Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01246362
First received: November 21, 2010
Last updated: August 3, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Drug: Control
Drug: Etoricoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: Within first 5 days after operation ] [ Designated as safety issue: No ]
  • Functional recovery postoperatively [ Time Frame: Within first 5 days after operation ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: July 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246362

Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Shi-lu Chia, MBBS Singapore General Hospital
  More Information

No publications provided

Responsible Party: Ang Chia Liang, Dr, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01246362     History of Changes
Other Study ID Numbers: ACL-3
Study First Received: November 21, 2010
Last Updated: August 3, 2014
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Osteoarthritis
Pain, Postoperative
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014