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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Acute Pain
Systemic Inflammatory Response Syndrome
Pathologic Processes
Postoperative Complications
Pain
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Shock

ClinicalTrials.gov processed this record on August 28, 2014