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Systemic Inflammation Versus Acute Pain in Total Knee Arthroplasty (TKA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322074
First Posted: March 24, 2011
Last Update Posted: October 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
  Purpose
In this study we evaluate if there is a correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA).

Condition
Other Acute Postoperative Pain Systemic Inflammatory Response Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relation Between Systemic Inflammatory Markers and Acute Pain in TKA

Resource links provided by NLM:


Further study details as provided by Troels Haxholdt Lunn, Hvidovre University Hospital:

Primary Outcome Measures:
  • Systemic inflammation vs. pain [ Time Frame: 1 week ]
    The correlation between pain and systemic inflammatory markers (CRP and IL6)


Biospecimen Retention:   Samples With DNA
Blood samples for C reactive protein and interleukin 6 analysis.

Enrollment: 120
Study Start Date: August 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Total knee arthroplasty
Patients operated with elective, unilateral total knee arthroplasty.

Detailed Description:

The correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA) is evaluated.

Level of systemic inflammatory markers (CRP and IL6) are measured preoperatively and 4 and 24 hours postoperatively. These measurements are correlated to postoperative pain (a detailed assessment of pain at rest and during ambulation).

We pole blood-samples collected prospectively (from two data set)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients operated with total knee arthroplasty
Criteria

Inclusion Criteria:

  • Elective unilateral primary total knee arthroplasty
  • Able to speak and understand danish
  • Able to give informed consent

Exclusion Criteria:

  • Alcohol or medical abuse
  • Allergies to local anesthetics or methylprednisolone
  • Age < 18 years old
  • Daily use of strong opioids or glucocorticoids
  • Pregnancy or breastfeeding (fertile women)
  • Bilateral / revision arthroplasty
  • Dementia or other cognitive dysfunction
  • Diabetic neuropathy, rheumatoid arthritis, and neurologic or psychiatric diseases potentially influencing pain perception
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322074


Locations
Denmark
Dep. of Anesthsiology, Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01322074     History of Changes
Other Study ID Numbers: 9991999
First Submitted: March 23, 2011
First Posted: March 24, 2011
Last Update Posted: October 17, 2011
Last Verified: October 2011

Keywords provided by Troels Haxholdt Lunn, Hvidovre University Hospital:
Acute postoperative pain
systemic inflammation
CRP
IL6

Additional relevant MeSH terms:
Pain, Postoperative
Acute Pain
Systemic Inflammatory Response Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Inflammation
Shock