Other Acute Postoperative PainNCT01322074
Systemic Inflammation Versus Acute Pain in Total Knee Arthroplasty (TKA)
An observational study of Other Acute Postoperative Pain and Systemic Inflammatory Response Syndrome, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
In this study we evaluate if there is a correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Acute Postoperative Pain, Systemic Inflammatory Response Syndrome
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Oct 2011
- Phase
- Observational
- 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
Study population: Patients operated with total knee arthroplasty
Who may be able to join
- Elective unilateral primary 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 old
- Daily use of strong opioids or glucocorticoids
- Pregnancy or breastfeeding (fertile women)
- Bilateral / revision arthroplasty
- Dementia or other cognitive dysfunction
- Diabetic neuropathy, rheumatoid arthritis, and neurologic or psychiatric diseases potentially influencing pain perception
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dep. of Anesthsiology, Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
About this study
Official title: The Relation Between Systemic Inflammatory Markers and Acute Pain in TKA
In this study we evaluate if there is a correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA).
Read the detailed description
The correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA) is evaluated.
Level of systemic inflammatory markers (CRP and IL6) are measured preoperatively and 4 and 24 hours postoperatively. These measurements are correlated to postoperative pain (a detailed assessment of pain at rest and during ambulation).
We pole blood-samples collected prospectively (from two data set)
- Keywords
- Acute postoperative pain, systemic inflammation, CRP, IL6
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty | Patients operated with elective, unilateral total knee arthroplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic inflammation vs. pain
The correlation between pain and systemic inflammatory markers (CRP and IL6)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startAug 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Acute 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Troels Haxholdt Lunn, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322074
- Sponsor's protocol ID
- 9991999
- Status last verified
- Oct 2011
- First submitted
- 23 Mar 2011
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Systemic Inflammatory Markers and Acute Pain in TKA
- ClinicalTrials.gov ID
- NCT01322074
- Acronym / sponsor ID
- 9991999
- Keywords
- Acute postoperative pain, systemic inflammation, CRP, IL6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Mar 2011 (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.
In this study we evaluate if there is a correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA).
Detailed description
The correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA) is evaluated.
Level of systemic inflammatory markers (CRP and IL6) are measured preoperatively and 4 and 24 hours postoperatively. These measurements are correlated to postoperative pain (a detailed assessment of pain at rest and during ambulation).
We pole blood-samples collected prospectively (from two data set)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty | – | –Patients operated with elective, unilateral total knee arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated with total knee arthroplasty
Key inclusion criteria (3 listed)
- Elective unilateral primary total knee arthroplasty
- Able to speak and understand danish
- Able to give informed consent
Key exclusion criteria (8 listed)
- Alcohol or medical abuse
- Allergies to local anesthetics or methylprednisolone
- Age < 18 years old
- Daily use of strong 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.
Primary outcome
Systemic inflammation vs. pain
Time frame: 1 week
The correlation between pain and systemic inflammatory markers (CRP and IL6)
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 17 Oct 2011.
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?
An observational study of Other Acute Postoperative Pain and Systemic Inflammatory Response Syndrome, 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 8 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 17 Oct 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Systemic inflammation vs. pain (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2011.