Back to resultsEffects of Methylprednisolone After Total Hip Arthroplasty
Primary Purpose
LOS, Postoperative Pain, Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Methylprednisolone
Sponsored by
About this trial
This is an interventional supportive care trial for LOS focused on measuring Hip arthroplasty, Methylprednisolone, Post-operative pain
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)
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Methylprednisolone
Saline
Arm Description
Methylprednisolone 125 mg iv pre-operatively
Saline iv pre-operatively in equivalent volume (placebo)
Outcomes
Primary Outcome Measures
Time to fulfill discharge criteria
Secondary Outcome Measures
Hand muscle strength
Sleeping 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.
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
Postoperative pain scores on the visual analog scale
Postoperative nausea and vomiting (PONV) on 4 point numeric range scale
Full Information
NCT ID
NCT00968903
First Posted
August 28, 2009
Last Updated
September 28, 2011
Sponsor
Hvidovre University Hospital
Collaborators
Lundbeck Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00968903
Brief Title
Effects of Methylprednisolone After Total Hip Arthroplasty
Official Title
Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Lundbeck Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LOS, Postoperative Pain, Postoperative Nausea and Vomiting, Sleeping Quality, Fatigue, Inflammatory Response
Keywords
Hip arthroplasty, Methylprednisolone, Post-operative pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
Methylprednisolone 125 mg iv pre-operatively
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline iv pre-operatively in equivalent volume (placebo)
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Methylprednisolone 125 mg iv pre-operatively
Primary Outcome Measure Information:
Title
Time to fulfill discharge criteria
Time Frame
At discharge (mean 1-2 days)
Secondary Outcome Measure Information:
Title
Hand muscle strength
Time Frame
24 hours
Title
Sleeping quality on the visual analog scale
Time Frame
up to four days
Title
Inflammatory response measured as CRP in blood sample
Time Frame
24 hours postoperatively
Title
Fatigue measured on a 10 point numeric range scale
Time Frame
up to four days
Title
Additional analgetics, antinausea agents and sleeping medicine.
Description
Measures as mg (analgetics) and daily use (yes or no)(antinausea agents and sleeping medicine).
Time Frame
up to four days
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
up to 30 days
Title
Postoperative pain scores on the visual analog scale
Time Frame
up 30 days
Title
Postoperative nausea and vomiting (PONV) on 4 point numeric range scale
Time Frame
up to 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Hvidovre University Hospital
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
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Effects of Methylprednisolone After Total Hip Arthroplasty
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