Effects of Methylprednisolone After Total Knee Arthroplasty
Information source: Hvidovre University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response
Intervention: Methylprednisolone (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hvidovre University Hospital
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.
Clinical Details
Official title: Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Postoperative pain
Secondary outcome: Postoperative nausea and vomiting (PONV)Sleeping quality Inflammatory response Additional analgetics, antinausea agents and sleeping medicine Time in hospital Fatigue
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Hvidovre University Hospital, Copenhagen, Hvidovre 2650, Denmark
Additional Information
Starting date: August 2009
Last updated: September 25, 2012
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