Postoperative PainNCT01323179
Preopioid Versus Nonopioid in Total Knee Arthroplasty (TKA)
An observational study of Postoperative Pain, run by Hvidovre University Hospital at 4 sites in Denmark.
Trial summary
Observational study evaluating pain response after total knee arthroplasty (TKA) in patients taking strong, weak or no opioids preoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- How many people
- 140 participants
- Where
- 4 sitesDenmark
- Study dates
- Mar 2011to Feb 2013
- 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 elective, primary, unilateral total knee artroplasty (TKA).
Who may be able to join
- Patients operated with elective, primary, unilateral total knee arthroplasty (TKA) (taking strong or weak opioid daily for minimum 4 weeks or opioid naive patients)
Who cannot join
- Bilateral / revision arthroplasty
- Disease affection central or peripheral nerve function
- Alcohol and medical abuse
- Daily use of glucocorticoids
- Malignancy
- BMI > 40
- Dementia or other cognitive dysfunction
- Treatment of anxiety or depression
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Dep. of Anesthesiology, Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
Dep. of ortopedic surgery, Gentofte Hospital
Hellerup, Hellerup, 2900
Dep. of ortopedic surgery, Regionshospitalet Holstebro
Holstebro, Holstebro, 7500
Dep. of ortopedic surgery, Vejle Sygehus
Vejle, Vejle, 7100
About this study
Official title: Acute Pain After Fast-track Total Knee Arthroplasty: Preoperative Opioid Versus Non-opioid
Observational study evaluating pain response after total knee arthroplasty (TKA) in patients taking strong, weak or no opioids preoperatively.
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Postoperative opioid requirements
- Medical subject headings
- 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 |
|---|---|---|
| Strong opioids | Patients taking strong opioids preoperatively | |
| Weak opioids | Patients taking weak opioids preoperatively | |
| Opioid native | Patients not taking opioids preoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain during ambulation and at rest
Measured: 24 hours
Secondary outcomes (2)
Pain
Pain during ambulation and at rest
Measured: 7 days
Opioid consumption
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 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, MD, Principal investigator, Dep. of Anesthesiology, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323179
- Sponsor's protocol ID
- 11123111
- Status last verified
- Jun 2013
- First submitted
- 24 Mar 2011
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pain After Fast-track Total Knee Arthroplasty: Preoperative Opioid Versus Non-opioid
- ClinicalTrials.gov ID
- NCT01323179
- Acronym / sponsor ID
- 11123111
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Postoperative opioid requirements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 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.
Observational study evaluating pain response after total knee arthroplasty (TKA) in patients taking strong, weak or no opioids preoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strong opioids | – | –Patients taking strong opioids preoperatively |
| Weak opioids | – | –Patients taking weak opioids preoperatively |
| Opioid native | – | –Patients not taking opioids preoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated with elective, primary, unilateral total knee artroplasty (TKA).
Key inclusion criteria (1 listed)
- Patients operated with elective, primary, unilateral total knee arthroplasty (TKA) (taking strong or weak opioid daily for minimum 4 weeks or opioid naive patients)
Key exclusion criteria (8 listed)
- Bilateral / revision arthroplasty
- Disease affection central or peripheral nerve function
- Alcohol and medical abuse
- Daily use of 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.
Primary outcome
Pain
Time frame: 24 hours
Pain during ambulation and at rest
2 secondary outcomes
Pain
Time frame: 7 days
Opioid consumption
Time frame: 7 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 5 Jun 2013.
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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, MD principal investigator
Dep. of Anesthesiology, Hvidovre University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Hvidovre University Hospital at 4 sites 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 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Pain (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 5 Jun 2013.