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

NCT01311804 | Unknown Phase 3

• 2 other identifiers: 02-2010Ministry of Health
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Unilateral Primary Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• Post operative pain control

  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.

  4 days

Secondary Outcomes (1)

• Number and duration of adverse events

  4 days

Study Arms (2)

periarticular parecoxib sodium

EXPERIMENTAL

patients will be given periarticular parecoxib sodium injection

Procedure: parecoxib sodium

intravenous parecoxib sodium

ACTIVE COMPARATOR

intravenous parecoxib sodium will be given during total knee arthroplasty

Procedure: parecoxib sodium

Interventions

parecoxib sodium PROCEDURE

periarticular parecoxib sodium injection will be given during total knee arthroplasty

Also known as: dynastat

periarticular parecoxib sodium

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead

Study Sites (1)

Hospital Tuanku Fauziah

Kangar, Perlis, 01000, Malaysia

Location

MeSH Terms

Interventions

parecoxib

Study Officials

• Yeap Ewe Juan

  MOH Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanthini Govindasamy

CONTACT

+603-26924249; shanthini@crc.gov.my

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 10, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 10, 2011

Record last verified: 2011-03

Locations

MY (1)