Pain, PostoperativeNCT01179204
Prediction of Pain in Total Knee Arthroplasty
An observational study of Pain, Postoperative, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
In this consecutive, prospective cohort study trial the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Preoperative heat stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Sep 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 (TKA)
Who may be able to join
- Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total knee arthroplasty.
Who cannot join
- Bilateral / revision arthroplasty
- Disease affection central or peripheral nerve function
- Alcohol and medical abuse
- Daily use of opioids or glucocorticoids
- Malignancy
- BMI > 40
- Depression
- Dementia or other cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Knee Arthroplasty?
In this consecutive, prospective cohort study trial the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total knee arthroplasty.
Read the detailed description
The preoperative heat stimulation consists of short and long tonic heat stimulation. Pain response is evaluated with an electronic visual analog scale.
Furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total knee arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).
- Conditions
- Pain, Postoperative
- Being tested
- Preoperative heat stimulation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative heat stimulationProcedure or surgery
Preoperative short and long tonic heat stimulation
| Study group | Role | What they receive |
|---|---|---|
| Patiens operated with TKA | Not described Receives: Procedure: Preoperative heat stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulated pain (from 0-24 hours after surgery)
Pain during walk 5 m (VAS)
Measured: 24 hours
Secondary outcomes (3)
Cumulated pain (from day 1 to day 7 after surgery)
Measured: 7 days
Pain at day 14 after surgery
Measured: 14 days
Pain at day 30 after surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- 100 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
- Investigators
- Troels H. Lunn, M.D, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179204
- Sponsor's protocol ID
- H-2-2010-052
- Status last verified
- Sep 2012
- First submitted
- 9 Aug 2010
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
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
- Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Knee Arthroplasty?
- ClinicalTrials.gov ID
- NCT01179204
- Acronym / sponsor ID
- H-2-2010-052
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Aug 2010 (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 consecutive, prospective cohort study trial the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total knee arthroplasty.
Detailed description
The preoperative heat stimulation consists of short and long tonic heat stimulation. Pain response is evaluated with an electronic visual analog scale.
Furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total knee arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patiens operated with TKA | – | Procedure: Preoperative heat stimulation |
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 (TKA)
Key inclusion criteria (1 listed)
- Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total knee arthroplasty.
Key exclusion criteria (8 listed)
- Bilateral / revision arthroplasty
- Disease affection central or peripheral nerve function
- Alcohol and medical abuse
- Daily use of opioids or glucocorticoids
- Malignancy
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 |
|---|---|---|
| Preoperative heat stimulationPreoperative short and long tonic heat stimulation | Procedure or surgery | Patiens operated with TKA |
Primary outcome
Cumulated pain (from 0-24 hours after surgery)
Time frame: 24 hours
Pain during walk 5 m (VAS)
3 secondary outcomes
Cumulated pain (from day 1 to day 7 after surgery)
Time frame: 7 days
Pain at day 14 after surgery
Time frame: 14 days
Pain at day 30 after surgery
Time frame: 30 days
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.
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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.
Troels H. Lunn, M.D principal investigator
Hvidovre University Hospital
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 Pain, Postoperative, 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 1 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 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. 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?
Cumulated pain (from 0-24 hours after surgery) (time frame: 24 hours). 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 26 Sep 2012.