Prediction of Pain in Total Knee Arthroplasty

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. Identifier: NCT01179204
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : September 26, 2012
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital

Brief Summary:
In this consecutive, prospective cohort study trial the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total knee arthroplasty.

Condition or disease Intervention/treatment
Pain, Postoperative Procedure: Preoperative heat stimulation

Detailed Description:

The preoperative heat stimulation consists of short and long tonic heat stimulation. Pain response is evaluated with an electronic visual analog scale.

Furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total knee arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Knee Arthroplasty?
Study Start Date : August 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
Patiens operated with TKA Procedure: Preoperative heat stimulation
Preoperative short and long tonic heat stimulation

Primary Outcome Measures :
  1. Cumulated pain (from 0-24 hours after surgery) [ Time Frame: 24 hours ]
    Pain during walk 5 m (VAS)

Secondary Outcome Measures :
  1. Cumulated pain (from day 1 to day 7 after surgery) [ Time Frame: 7 days ]
  2. Pain at day 14 after surgery [ Time Frame: 14 days ]
  3. Pain at day 30 after surgery [ Time Frame: 30 days ]

Biospecimen Retention:   Samples With DNA

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 (TKA)

Inclusion Criteria:

  • Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total knee arthroplasty.

Exclusion Criteria:

  • Bilateral / revision arthroplasty
  • Disease affection central or peripheral nerve function
  • Alcohol and medical abuse
  • Daily use of opioids or glucocorticoids
  • Malignancy
  • BMI > 40
  • Depression
  • Dementia or other cognitive dysfunction

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 identifier (NCT number): NCT01179204

Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Principal Investigator: Troels H. Lunn, M.D Hvidovre University Hospital

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital Identifier: NCT01179204     History of Changes
Other Study ID Numbers: H-2-2010-052
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms