Postoperative PainPhase 4NCT00968578
Effects of Methylprednisolone After Total Knee Arthroplasty
A Phase 4 study testing Methylprednisolone in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after knee arthroplasty. The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and improve outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea and Vomiting, Sleeping Quality
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective total knee arthroplasty
- Able to speak and understand danish
- Able to give informed consent
Who cannot join
- Alcohol or medical abuse
- Allergies to local anesthetics or methylprednisolone
- Age < 18 years
- Daily use of opioids or glucocorticoids
- Pregnancy or breastfeeding (fertile women)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after knee arthroplasty.
The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and improve outcome.
Read the detailed description
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total knee arthroplasty is still associated with postoperative pain and delayed rehabilitation. We 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 knee arthroplasty.
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Sleeping Quality, Fatigue, Inflammatory Response
- Being tested
- Methylprednisolone, Placebo
- Keywords
- Knee arthroplasty, Methylprednisolone, Post-operative pain
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone 125 mg iv pre-operatively
PlaceboDrug
Saline iv pre-operatively in equivalent volume (placebo)
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | Methylprednisolone 125 mg iv pre-operatively Receives: Drug: Methylprednisolone |
| Saline | Placebo comparator | Saline iv pre-operatively in equivalent volume (placebo) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Measured: 48 hours + follow up
Secondary outcomes (6)
Postoperative nausea and vomiting (PONV)
Measured: 48 hours + follow up
Sleeping quality
Measured: 48 hours + follow up
Inflammatory response
Measured: 48 hours + follow up
Additional analgetics, antinausea agents and sleeping medicine
Measured: 48 hours + follow up
Time in hospital
Measured: Until discharge
Fatigue
Measured: 48 hours + follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Troels Haxholdt Lunn, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968578
- Sponsor's protocol ID
- H-C-2008-134
- Other IDs
- 2009-41-3786
- Status last verified
- Sep 2012
- First submitted
- 28 Aug 2009
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3.
PubMed 21131371
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
- ClinicalTrials.gov ID
- NCT00968578
- Acronym / sponsor ID
- H-C-2008-134
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Sleeping Quality, Fatigue, Inflammatory Response
- Keywords
- Knee arthroplasty, Methylprednisolone, Post-operative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after knee arthroplasty.
The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce pain and improve outcome.
Detailed description
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total knee arthroplasty is still associated with postoperative pain and delayed rehabilitation. We 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 knee arthroplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: MethylprednisoloneMethylprednisolone 125 mg iv pre-operatively |
| Saline | Placebo comparator | Drug: PlaceboSaline iv pre-operatively in equivalent volume (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective total knee arthroplasty
- Able to speak and understand danish
- Able to give informed consent
Key exclusion criteria (5 listed)
- Alcohol or medical abuse
- Allergies to local anesthetics or methylprednisolone
- Age < 18 years
- Daily use of opioids or glucocorticoids
- Pregnancy or breastfeeding (fertile women)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneMethylprednisolone 125 mg iv pre-operatively | Drug | Methylprednisolone |
| PlaceboSaline iv pre-operatively in equivalent volume (placebo) | Drug | Saline |
Primary outcome
Postoperative pain
Time frame: 48 hours + follow up
6 secondary outcomes
Postoperative nausea and vomiting (PONV)
Time frame: 48 hours + follow up
Sleeping quality
Time frame: 48 hours + follow up
Inflammatory response
Time frame: 48 hours + follow up
Additional analgetics, antinausea agents and sleeping medicine
Time frame: 48 hours + follow up
Time in hospital
Time frame: Until discharge
Fatigue
Time frame: 48 hours + follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
- Derived from this study: PubMed 21131371Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 48 hours + follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00968578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.