Effects of Methylprednisolone After Total Hip 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 hip arthroplasty. The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria.

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 hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. The investigators 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 hip arthroplasty.

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

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

Intervention / Treatment
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* Drug: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective total hip 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: Methylprednisolone<br>* Methylprednisolone 125 mg iv pre-operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fulfill discharge criteria |  | At discharge (mean 1-2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand muscle strength |  | 24 hours | 
| Sleeping quality on the visual analog scale |  | up to four days | 
| Inflammatory response measured as CRP in blood sample |  | 24 hours postoperatively | 
| Fatigue measured on a 10 point numeric range scale |  | up to four days | 
| Additional analgetics, antinausea agents and sleeping medicine. | Measures as mg (analgetics) and daily use (yes or no)(antinausea agents and sleeping medicine). | up to four days | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | up to 30 days | 
| Postoperative pain scores on the visual analog scale |  | up 30 days | 
| Postoperative nausea and vomiting (PONV) on 4 point numeric range scale |  | up to 4 days | 

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