Effects of Methylprednisolone After Total Hip 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: LOS; Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response
Intervention: Methylprednisolone (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 hip arthroplasty.
The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to
fulfill discharge criteria.
Clinical Details
Official title: Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip 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: Time to fulfill discharge criteria
Secondary outcome: Hand muscle strengthSleeping quality on the visual analog scale Inflammatory response measured as CRP in blood sample Fatigue measured on a 10 point numeric range scale Additional analgetics, antinausea agents and sleeping medicine. Number of Participants with Adverse Events as a Measure of Safety and Tolerability Postoperative pain scores on the visual analog scale Postoperative nausea and vomiting (PONV) on 4 point numeric range scale
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Hvidovre University Hospital, Copenhagen, Hvidovre 2650, Denmark
Additional Information
Starting date: April 2010
Last updated: September 28, 2011
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