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Effects of Methylprednisolone After Total Knee Arthroplasty

Primary Purpose

Postoperative Pain, Postoperative Nausea and Vomiting, Sleeping Quality

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Methylprednisolone
Placebo
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Knee arthroplasty, Methylprednisolone, Post-operative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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

Postoperative pain

Secondary Outcome Measures

Postoperative nausea and vomiting (PONV)
Sleeping quality
Inflammatory response
Additional analgetics, antinausea agents and sleeping medicine
Time in hospital
Fatigue

Full Information

First Posted
August 28, 2009
Last Updated
September 25, 2012
Sponsor
Hvidovre University Hospital
Collaborators
Lundbeck Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00968578
Brief Title
Effects of Methylprednisolone After Total Knee Arthroplasty
Official Title
Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Nausea and Vomiting, Sleeping Quality, Fatigue, Inflammatory Response
Keywords
Knee 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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline iv pre-operatively in equivalent volume (placebo)
Primary Outcome Measure Information:
Title
Postoperative pain
Time Frame
48 hours + follow up
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting (PONV)
Time Frame
48 hours + follow up
Title
Sleeping quality
Time Frame
48 hours + follow up
Title
Inflammatory response
Time Frame
48 hours + follow up
Title
Additional analgetics, antinausea agents and sleeping medicine
Time Frame
48 hours + follow up
Title
Time in hospital
Time Frame
Until discharge
Title
Fatigue
Time Frame
48 hours + follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Hvidovre University Hospital
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
21131371
Citation
Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3.
Results Reference
derived

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Effects of Methylprednisolone After Total Knee Arthroplasty

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