Effects of Methylprednisolone After Total Hip Arthroplasty

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968903
• Other study ID #: H-A-2008-030
• Secondary ID: 2009-41-37842612
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2009
• Last updated: September 28, 2011
• Start date: April 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2011
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatigue
• Inflammatory Response
• LOS
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Sleeping Quality

Intervention

Drug:
• Methylprednisolone
Methylprednisolone 125 mg iv pre-operatively

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Copenhagen	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to fulfill discharge criteria		At discharge (mean 1-2 days)	No
Secondary	Hand muscle strength		24 hours	No
Secondary	Sleeping quality on the visual analog scale		up to four days	No
Secondary	Inflammatory response measured as CRP in blood sample		24 hours postoperatively	No
Secondary	Fatigue measured on a 10 point numeric range scale		up to four days	No
Secondary	Additional analgetics, antinausea agents and sleeping medicine.	Measures as mg (analgetics) and daily use (yes or no)(antinausea agents and sleeping medicine).	up to four days	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		up to 30 days	Yes
Secondary	Postoperative pain scores on the visual analog scale		up 30 days	No
Secondary	Postoperative nausea and vomiting (PONV) on 4 point numeric range scale		up to 4 days	No