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Completed

NCT Number: NCT00968903

Effects of Methylprednisolone After Total Hip Arthroplasty

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.

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Key information

Conditions

LOS Fatigue Inflammatory Response Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Pain Signs and Symptoms Signs and Symptoms, Digestive Sleeping Quality Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

methylprednisolone

Drug

Methylprednisolone 125 mg iv pre-operatively

Primary outcomes

  1. Time to fulfill discharge criteria

    Time frame: At discharge (mean 1-2 days)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 31, 2009
Registry last updated
Sep 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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