Effects of Methylprednisolone After Total Hip Arthroplasty
This study has been completed.
Sponsor:
Hvidovre University Hospital
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
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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:
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
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 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:
|
Fatigue Pain, Postoperative Vomiting Postoperative Nausea and Vomiting Signs and Symptoms Postoperative Complications Pathologic Processes Pain Signs and Symptoms, Digestive Nausea 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 Neuroprotective Agents Protective Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 16, 2013