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

Systemic Inflammatory Response Syndrome Clinical Trial

Official title:

The Relation Between Systemic Inflammatory Markers and Acute Pain in TKA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322074
• Other study ID #: 9991999
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: October 14, 2011
• Start date: August 2009
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pain
• Other Acute Postoperative Pain
• Pain, Postoperative
• Systemic Inflammatory Response Syndrome

Locations

Country	Name	City	State
Denmark	Dep. of Anesthsiology, Hvidovre University Hospital	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic inflammation vs. pain	The correlation between pain and systemic inflammatory markers (CRP and IL6)	1 week	No