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Completed

NCT Number: NCT00968578

Effects of Methylprednisolone After Total Knee Arthroplasty

The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after knee arthroplasty.

The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and improve outcome.

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Key information

Conditions

Postoperative Pain Fatigue Inflammatory Response Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Sleeping Quality Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

About this study

In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total knee arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after knee arthroplasty.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective 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
  • Daily use of opioids or glucocorticoids
  • Pregnancy or breastfeeding (fertile women)

Treatment and study plan

methylprednisolone

Drug

Methylprednisolone 125 mg iv pre-operatively

Placebo

Drug

Saline iv pre-operatively in equivalent volume (placebo)

Primary outcomes

  1. Postoperative pain

    Time frame: 48 hours + follow up

Secondary outcomes

  1. Postoperative nausea and vomiting (PONV)

    Time frame: 48 hours + follow up

  2. Sleeping quality

    Time frame: 48 hours + follow up

  3. Inflammatory response

    Time frame: 48 hours + follow up

  4. Additional analgetics, antinausea agents and sleeping medicine

    Time frame: 48 hours + follow up

  5. Time in hospital

    Time frame: Until discharge

  6. Fatigue

    Time frame: 48 hours + follow up

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 31, 2009
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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