Prediction of Pain in Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01179204
First received: August 9, 2010
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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 Intervention
Pain, Postoperative
Procedure: Preoperative heat stimulation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Knee Arthroplasty?

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Cumulated pain (from 0-24 hours after surgery) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain during walk 5 m (VAS)


Secondary Outcome Measures:
  • Cumulated pain (from day 1 to day 7 after surgery) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Pain at day 14 after surgery [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Pain at day 30 after surgery [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood-samples


Enrollment: 100
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patiens operated with TKA Procedure: Preoperative heat stimulation
Preoperative short and long tonic 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).

  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 (TKA)

Criteria

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
  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: NCT01179204

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

No publications provided

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01179204     History of Changes
Other Study ID Numbers: H-2-2010-052
Study First Received: August 9, 2010
Last Updated: September 25, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014