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OpenTrials
Completed

NCT Number: NCT01323179

Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)

Observational study evaluating pain response after total knee arthroplasty (TKA) in patients taking strong, weak or no opioids preoperatively.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of ortopedic surgery, Gentofte Hospital, Hellerup, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients operated with elective, primary, unilateral total knee arthroplasty (TKA) (taking strong or weak opioid daily for minimum 4 weeks or opioid naive patients)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Pain

    Time frame: 24 hours

    Pain during ambulation and at rest

Secondary outcomes

  1. Pain

    Time frame: 7 days

    Pain during ambulation and at rest

  2. Opioid consumption

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Acute Pain After Fast-track Total Knee Arthroplasty: Preoperative Opioid Versus Non-opioid

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 25, 2011
Registry last updated
Jun 5, 2013

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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