Effects of Methylprednisolone After Total Knee Arthroplasty

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Sleeping Quality; Postoperative Nausea and Vomiting; Inflammatory Response; Fatigue

Treatments: Drug: Methylprednisolone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00968578

2009-41-3786

H-C-2008-134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Methylprednisolone

Active Comparator group

Description:

Methylprednisolone 125 mg iv pre-operatively

Treatment:

Drug: Methylprednisolone

Saline

Placebo Comparator group

Description:

Saline iv pre-operatively in equivalent volume (placebo)

Treatment:

Drug: Placebo