Fatigue, Inflammatory Response, LOS, Postoperative Nausea and Vomiting, Postoperative Pain, Sleeping Quality
Conditions
Keywords
Hip arthroplasty, Methylprednisolone, Post-operative pain
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.
Interventions
DRUGMethylprednisolone
Methylprednisolone 125 mg iv pre-operatively
Sponsors
Lundbeck Foundation
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to fulfill discharge criteria | At discharge (mean 1-2 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Postoperative nausea and vomiting (PONV) on 4 point numeric range scale | up to 4 days | — |
| Additional analgetics, antinausea agents and sleeping medicine. | up to four days | Measures as mg (analgetics) and daily use (yes or no)(antinausea agents and sleeping medicine). |
| 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 | — |
| Fatigue measured on a 10 point numeric range scale | up to four days | — |
Countries
Denmark
Outcome results
None listed