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Effects of Methylprednisolone After Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT00968903
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : September 29, 2011
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital

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.


Condition or disease Intervention/treatment Phase
LOS Postoperative Pain Postoperative Nausea and Vomiting Sleeping Quality Fatigue Inflammatory Response Drug: Methylprednisolone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Time to fulfill discharge criteria [ Time Frame: At discharge (mean 1-2 days) ]

Secondary Outcome Measures :
  1. Hand muscle strength [ Time Frame: 24 hours ]
  2. Sleeping quality on the visual analog scale [ Time Frame: up to four days ]
  3. Inflammatory response measured as CRP in blood sample [ Time Frame: 24 hours postoperatively ]
  4. Fatigue measured on a 10 point numeric range scale [ Time Frame: up to four days ]
  5. Additional analgetics, antinausea agents and sleeping medicine. [ Time Frame: up to four days ]
    Measures as mg (analgetics) and daily use (yes or no)(antinausea agents and sleeping medicine).

  6. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 30 days ]
  7. Postoperative pain scores on the visual analog scale [ Time Frame: up 30 days ]
  8. Postoperative nausea and vomiting (PONV) on 4 point numeric range scale [ Time Frame: up to 4 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968903


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

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
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: September 2011

Keywords provided by Troels Haxholdt Lunn, Hvidovre University Hospital:
Hip arthroplasty
Methylprednisolone
Post-operative pain

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