Effects of Methylprednisolone After Total Knee Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00968578
First received: August 28, 2009
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Postoperative Nausea and Vomiting
Sleeping Quality
Fatigue
Inflammatory Response
Drug: Methylprednisolone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative nausea and vomiting (PONV) [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ]
  • Sleeping quality [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ]
  • Inflammatory response [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ]
  • Additional analgetics, antinausea agents and sleeping medicine [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ]
  • Time in hospital [ Time Frame: Until discharge ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: 48 hours + follow up ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methylprednisolone
Methylprednisolone 125 mg iv pre-operatively
Drug: Methylprednisolone
Methylprednisolone 125 mg iv pre-operatively
Placebo Comparator: Saline
Saline iv pre-operatively in equivalent volume (placebo)
Drug: Placebo
Saline iv pre-operatively in equivalent volume (placebo)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968578

Locations
Denmark
Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Lundbeck Foundation
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00968578     History of Changes
Other Study ID Numbers: H-C-2008-134, 2009-41-3786
Study First Received: August 28, 2009
Last Updated: September 25, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Knee arthroplasty
Methylprednisolone
Post-operative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Nausea and Vomiting
Nausea
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Vomiting
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014