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Completed

NCT Number: NCT01179204

Prediction of Pain in Total Knee Arthroplasty

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative heat stimulation

Procedure

Preoperative short and long tonic heat stimulation

Primary outcomes

  1. Cumulated pain (from 0-24 hours after surgery)

    Time frame: 24 hours

    Pain during walk 5 m (VAS)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Knee Arthroplasty?

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2010
Registry last updated
Sep 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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