An Efficacy and Safety Study of Periarticular Parecoxib Sodium for Pain Management in Total Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Ministry of Health, Malaysia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT01311804
First received: March 3, 2011
Last updated: March 8, 2011
Last verified: March 2011
  Purpose

Primary Research Objective:

The primary objective of this study is to determine efficacy of periarticular parecoxib sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management in total knee arthroplasty

Secondary Research Objective:

  • To determine if perioperative use of parecoxib sodium was associated with improved clinical outcomes
  • To evaluate the safety, in terms of adverse events; serious adverse events and tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail

Condition Intervention Phase
Unilateral Primary Osteoarthritis of Knee
Procedure: parecoxib sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label,Multicentre, Randomized Trial to Determine the Efficacy of Periarticular Parecoxib Sodium In A Multimodal Cocktail vs Intravenous Parecoxib Sodium for Pain Management in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Malaysia:

Primary Outcome Measures:
  • Post operative pain control [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Post operative pain control( Visual Analogue Scale) with 0 corresponding to "no pain" and 10 to" the worst imaginable pain". Pain will be measured 1st 6 hours, 12 hours, 24 hours and daily for 4 days.


Secondary Outcome Measures:
  • Number and duration of adverse events [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    • Morphine consumption
    • Metochlopromide usage during the 4 days
    • Lactulose usage during the 4 days
    • Range of motion measured by physiotherapist at 24 hours and daily for 4 days
    • time to single leg raise
    • time to ambulation


Estimated Enrollment: 125
Study Start Date: April 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: periarticular parecoxib sodium
patients will be given periarticular parecoxib sodium injection
Procedure: parecoxib sodium
periarticular parecoxib sodium injection will be given during total knee arthroplasty
Other Name: dynastat
Active Comparator: intravenous parecoxib sodium
intravenous parecoxib sodium will be given during total knee arthroplasty
Procedure: parecoxib sodium
intravenous parecoxib sodium during total knee arthroplasty
Other Name: dynastat

Detailed Description:

This is a multi-center, open label, parallel randomized trial designed to evaluate the efficacy and safety of periarticular parecoxib sodium compared to intravenous parecoxib sodium.

125 patients with primary knee osteoarthritis from 4 participating sites who meet inclusion/exclusion criteria will be enrolled into the trial. After initial screening, patients will attend clinic for baseline examination. Subjects will then randomly allocated to periarticular parecoxib sodium or intravenous sodium in ratio of 1:1. patients are observed at post-operative 6, 12, 24 hours, subsequently daily for 4 days and finally at 2 week follow-up

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary knee osteoarthritis on treatment and planned for unilateral total knee arthroplasty and on spinal/general anesthesia
  • Subjects age more than 50 and less than 85 years
  • Patients with body weight at least 50 kg and not more than 50%above ideal body weight
  • Written informed consent obtained from patient or guardian

Exclusion Criteria:

  • Female patients who are attempting to conceive/pregnant
  • Known allergy or hypersensitivity to cocktail regime or to COX-2 inhibitors
  • History of bleeding disorders or coagulation defect
  • Patients with abnormal liver profile
  • Patients with history of stroke or major neurological defect
  • Patients with neuropathic pain/sensory disorder
  • Patients with peptic ulceration or anticoagulant use within 1 month
  • History of previous major knee surgery/trauma
  • Patients with renal insufficiency
  • History of revision total knee arthroplasty
  • Patients with knee deformity > 20 degrees
  • Patients planned for bilateral knee arthroplasty during the same setting
  • Patients with significant bone loss requiring augmentation
  • Patients with history of using NSAIDs 24 hours before the surgery
  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: NCT01311804

Contacts
Contact: Shanthini Govindasamy +603-26924249 shanthini@crc.gov.my

Locations
Malaysia
Hospital Tuanku Fauziah Not yet recruiting
Kangar, Perlis, Malaysia, 01000
Contact: Yeap Ewe Juan    +604-976 3333      
Principal Investigator: Yeap Ewe Juan         
Sponsors and Collaborators
Ministry of Health, Malaysia
Investigators
Principal Investigator: Yeap Ewe Juan MOH Malaysia
  More Information

No publications provided

Responsible Party: Dr. Yeap Ewe Juan, Name/Official Title: Dr. Yeap Ewe Juan
ClinicalTrials.gov Identifier: NCT01311804     History of Changes
Other Study ID Numbers: 02-2010, Ministry of Health
Study First Received: March 3, 2011
Last Updated: March 8, 2011
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Parecoxib
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 August 28, 2014