Effects of Methylprednisolone After Total Hip Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00968903
First received: August 28, 2009
Last updated: September 28, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
LOS
Postoperative Pain
Postoperative Nausea and Vomiting
Sleeping Quality
Fatigue
Inflammatory Response
Drug: Methylprednisolone
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 Hip 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:
  • Time to fulfill discharge criteria [ Time Frame: At discharge (mean 1-2 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hand muscle strength [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Sleeping quality on the visual analog scale [ Time Frame: up to four days ] [ Designated as safety issue: No ]
  • Inflammatory response measured as CRP in blood sample [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
  • Fatigue measured on a 10 point numeric range scale [ Time Frame: up to four days ] [ Designated as safety issue: No ]
  • Additional analgetics, antinausea agents and sleeping medicine. [ Time Frame: up to four days ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
  • Postoperative pain scores on the visual analog scale [ Time Frame: up 30 days ] [ Designated as safety issue: No ]
  • Postoperative nausea and vomiting (PONV) on 4 point numeric range scale [ Time Frame: up to 4 days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (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: Methylprednisolone
Methylprednisolone 125 mg iv pre-operatively

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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: NCT00968903

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

No publications provided

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00968903     History of Changes
Other Study ID Numbers: H-A-2008-030, 2009-41-3784, 2612-3916, EudraCT: 2008-006528-67
Study First Received: August 28, 2009
Last Updated: September 28, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on October 16, 2014