Effects of Methylprednisolone After Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response
• Interventions: Drug: Placebo; Drug: Methylprednisolone

• Registration Number: NCT00968578
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	Saline iv pre-operatively in equivalent volume (placebo)
Methylprednisolone	Methylprednisolone	Methylprednisolone 125 mg iv pre-operatively

Primary Outcome Measures

Name	Time	Method
Postoperative pain	48 hours + follow up

Secondary Outcome Measures

Name	Time	Method
Fatigue	48 hours + follow up
Postoperative nausea and vomiting (PONV)	48 hours + follow up
Sleeping quality	48 hours + follow up
Inflammatory response	48 hours + follow up
Additional analgetics, antinausea agents and sleeping medicine	48 hours + follow up
Time in hospital	Until discharge

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark