Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
Overview
- Phase
- Phase 4
- Intervention
- Methylprednisolone
- Conditions
- Postoperative Pain
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Postoperative pain
- Status
- Completed
- Last Updated
- 13 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 knee arthroplasty.
The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and improve outcome.
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.
Investigators
Troels Haxholdt Lunn
MD
Hvidovre University Hospital
Eligibility 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)
Arms & Interventions
Methylprednisolone
Methylprednisolone 125 mg iv pre-operatively
Intervention: Methylprednisolone
Saline
Saline iv pre-operatively in equivalent volume (placebo)
Intervention: Placebo
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: 48 hours + follow up
Secondary Outcomes
- Fatigue(48 hours + follow up)
- 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)