CClinicalTrials.gg
CompletedNCT00968578Updated Sep 26, 2012

Effects of Methylprednisolone After Total Knee Arthroplasty

A Phase 4 interventional study of Methylprednisolone and Placebo in Postoperative Pain, Postoperative Nausea and Vomiting and Sleeping Quality, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-26.

Sponsored by Hvidovre University Hospital · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Postoperative Pain
  • Postoperative Nausea and Vomiting
  • Sleeping Quality
  • Fatigue
  • Inflammatory Response

Keywords

  • Knee arthroplasty
  • Methylprednisolone
  • Post-operative pain
03

In context

Vomiting

1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.

This study's enrollment of 48 is below the median of 107 across 935 interventional studies indexed under Vomiting.

Browse Vomiting studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Elective total knee arthroplasty
  • Able to speak and understand danish
  • Able to give informed consent

Exclusion criteria

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)
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Methylprednisolone

    Methylprednisolone 125 mg iv pre-operatively

    Drug: Methylprednisolone

  • Placebo comparator
    Saline

    Saline iv pre-operatively in equivalent volume (placebo)

    Drug: Placebo

Interventions

  • DrugMethylprednisolone

    Methylprednisolone 125 mg iv pre-operatively

  • DrugPlacebo

    Saline iv pre-operatively in equivalent volume (placebo)

06

What researchers measure

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

07

Study locations

1 site
  • Hvidovre University Hospital
    Copenhagen, Hvidovre 2650, Denmark
08

References and documents

Publications

  • Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3. PubMed 21131371 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00968578
Lead sponsor
Hvidovre University Hospital
Collaborators
Lundbeck Foundation
Responsible party
Troels Haxholdt Lunn (MD, Hvidovre University Hospital) — Principal investigator
First posted
Aug 31, 2009
Start date
Aug 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Sep 26, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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