Effects of Methylprednisolone After Total Hip Arthroplasty

Phase 4

Completed

• Conditions: LOS; Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response
• Interventions: Drug: Methylprednisolone

• Registration Number: NCT00968903
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Study Start: 2010-04
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-28
• Last Update Posted: 2011-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Methylprednisolone	Saline iv pre-operatively in equivalent volume (placebo)
Methylprednisolone	Methylprednisolone	Methylprednisolone 125 mg iv pre-operatively

Primary Outcome Measures

Name	Time	Method
Time to fulfill discharge criteria	At discharge (mean 1-2 days)

Secondary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting (PONV) on 4 point numeric range scale	up to 4 days
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	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

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark