Effects of Methylprednisolone After Total Knee Arthroplasty

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00968578

Enrollment

Registered

2009-08-31

Start date

2009-08-31

Completion date

2009-12-31

Last updated

2012-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Knee arthroplasty, Methylprednisolone, Post-operative pain

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.

Interventions

DRUGMethylprednisolone

Methylprednisolone 125 mg iv pre-operatively

DRUGPlacebo

Saline iv pre-operatively in equivalent volume (placebo)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Postoperative pain	48 hours + follow up

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026