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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01322074
First received: March 23, 2011
Last updated: October 14, 2011
Last verified: October 2011
History of Changes
  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:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Systemic inflammation vs. pain [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322074

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

No publications provided

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01322074     History of Changes
Other Study ID Numbers: 9991999
Study First Received: March 23, 2011
Last Updated: October 14, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Acute postoperative pain
systemic inflammation
CRP
IL6

Additional relevant MeSH terms:
Inflammation
Pain, Postoperative
Systemic Inflammatory Response Syndrome
Pathologic Processes
 Postoperative Complications
Pain
Signs and Symptoms
Shock

ClinicalTrials.gov processed this record on June 18, 2013