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

Primary Purpose

Unilateral Primary Osteoarthritis of Knee

Status
Unknown status
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
parecoxib sodium
parecoxib sodium
Sponsored by
Ministry of Health, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Primary Osteoarthritis of Knee

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Tuanku Fauziah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

periarticular parecoxib sodium

intravenous parecoxib sodium

Arm Description

patients will be given periarticular parecoxib sodium injection

intravenous parecoxib sodium will be given during total knee arthroplasty

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number and duration of adverse events
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

Full Information

First Posted
March 3, 2011
Last Updated
March 8, 2011
Sponsor
Ministry of Health, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT01311804
Brief Title
An Efficacy and Safety Study of Periarticular Parecoxib Sodium for Pain Management in Total Knee Arthroplasty
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Malaysia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Primary Osteoarthritis of Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
periarticular parecoxib sodium
Arm Type
Experimental
Arm Description
patients will be given periarticular parecoxib sodium injection
Arm Title
intravenous parecoxib sodium
Arm Type
Active Comparator
Arm Description
intravenous parecoxib sodium will be given during total knee arthroplasty
Intervention Type
Procedure
Intervention Name(s)
parecoxib sodium
Other Intervention Name(s)
dynastat
Intervention Description
periarticular parecoxib sodium injection will be given during total knee arthroplasty
Intervention Type
Procedure
Intervention Name(s)
parecoxib sodium
Other Intervention Name(s)
dynastat
Intervention Description
intravenous parecoxib sodium during total knee arthroplasty
Primary Outcome Measure Information:
Title
Post operative pain control
Description
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.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Number and duration of adverse events
Description
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
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shanthini Govindasamy
Phone
+603-26924249
Email
shanthini@crc.gov.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeap Ewe Juan
Organizational Affiliation
MOH Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Tuanku Fauziah
City
Kangar
State/Province
Perlis
ZIP/Postal Code
01000
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeap Ewe Juan
Phone
+604-976 3333
First Name & Middle Initial & Last Name & Degree
Yeap Ewe Juan

12. IPD Sharing Statement

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

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