Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
Overview
- Phase
- Phase 4
- Intervention
- Methylprednisolone
- Conditions
- LOS
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Time to fulfill discharge criteria
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
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.
Investigators
Troels Haxholdt Lunn
MD
Hvidovre University Hospital
Eligibility 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)
Arms & Interventions
Methylprednisolone
Methylprednisolone 125 mg iv pre-operatively
Intervention: Methylprednisolone
Saline
Saline iv pre-operatively in equivalent volume (placebo)
Intervention: Methylprednisolone
Outcomes
Primary Outcomes
Time to fulfill discharge criteria
Time Frame: At discharge (mean 1-2 days)
Secondary Outcomes
- 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.(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)