Effects of Methylprednisolone After Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylprednisolone<br>Methylprednisolone 125 mg iv pre-operatively | Drug: Methylprednisolone<br>* Methylprednisolone 125 mg iv pre-operatively<br>|
| Placebo Comparator: Saline<br>Saline iv pre-operatively in equivalent volume (placebo) | Drug: Placebo<br>* Saline iv pre-operatively in equivalent volume (placebo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain |  | 48 hours + follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Fatigue |  | 48 hours + follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee arthroplasty, Methylprednisolone, Post-operative pain