NCT00968578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

4 months

First QC Date

August 28, 2009

Last Update Submit

September 25, 2012

Conditions

Postoperative PainPostoperative Nausea and VomitingSleeping QualityFatigueInflammatory Response

Keywords

Knee arthroplastyMethylprednisolonePost-operative pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    48 hours + follow up

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Methylprednisolone

ACTIVE COMPARATOR

Methylprednisolone 125 mg iv pre-operatively

Drug: Methylprednisolone

Saline

PLACEBO COMPARATOR

Saline iv pre-operatively in equivalent volume (placebo)

Drug: Placebo

Interventions

MethylprednisoloneDRUG

Methylprednisolone 125 mg iv pre-operatively

Methylprednisolone
PlaceboDRUG

Saline iv pre-operatively in equivalent volume (placebo)

Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective total knee arthroplasty
  • Able to speak and understand danish
  • Able to give informed consent

You may not qualify if:

  • Alcohol or medical abuse
  • Allergies to local anesthetics or methylprednisolone
  • Age \< 18 years
  • Daily use of opioids or glucocorticoids
  • Pregnancy or breastfeeding (fertile women)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 21131371DERIVED

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and VomitingFatigue

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

DK(1)