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

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ClinicalTrials.gov Identifier: NCT01322074
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : October 17, 2011
Sponsor:
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital

Brief Summary:
In this study we evaluate if there is a correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA).

Condition or disease
Other Acute Postoperative Pain Systemic Inflammatory Response Syndrome

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)


Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relation Between Systemic Inflammatory Markers and Acute Pain in TKA
Study Start Date : August 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort
Total knee arthroplasty
Patients operated with elective, unilateral total knee arthroplasty.



Primary Outcome Measures :
  1. 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01322074     History of Changes
Other Study ID Numbers: 9991999
First Posted: March 24, 2011    Key Record Dates
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