Effects of Methylprednisolone After Total Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968578
• Other study ID #: H-C-2008-134
• Secondary ID: 2009-41-3786
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2009
• Last updated: September 25, 2012
• Start date: August 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2012
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Drug:
• Methylprednisolone
Methylprednisolone 125 mg iv pre-operatively
• Placebo
Saline iv pre-operatively in equivalent volume (placebo)

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Copenhagen	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain		48 hours + follow up	No
Secondary	Postoperative nausea and vomiting (PONV)		48 hours + follow up	No
Secondary	Sleeping quality		48 hours + follow up	No
Secondary	Inflammatory response		48 hours + follow up	No
Secondary	Additional analgetics, antinausea agents and sleeping medicine		48 hours + follow up	No
Secondary	Time in hospital		Until discharge	No
Secondary	Fatigue		48 hours + follow up	No