Postoperative PainPhase 4NCT00408707
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty
A Phase 4 study testing local infiltration analgesia in people with Postoperative Pain, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after total knee arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- local infiltration analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Dec 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients eligible for total knee arthroplasty
- must speak and understand Danish
- must be able to give oral and written consent
Who cannot join
- Alcohol or medicine abuse
- Treatment with opioids
- Allergy to local anaesthetics
- Severe obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty: a Placebo Controlled, Randomized, Double-Blinded Study.
The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after total knee arthroplasty.
Read the detailed description
Total knee arthroplasty (TKA) is increasingly common in the treatment of osteoarthrosis. Despite aggressive analgesic regimes, TKA is associated with moderate to severe postoperative pain, delaying mobilization and hospital discharge. A relatively new method for controlling postoperative pain after TKA is local infiltration analgesia (LIA) which consists of local infiltration with Ropivacaine and adrenaline.3 studies haved showed promising results of LIA, but none have documented a superior analgesic effect versus placebo.Patients receiving bilateral knee arthroplasty are recruited to receive LIA and placebo infiltration.The aim of the study is to demonstrate an analgesic effect of LIA versus placebo.
- Conditions
- Postoperative Pain
- Being tested
- local infiltration analgesia
- Keywords
- local infiltration analgesia, postoperative pain, ropivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local infiltration analgesiaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Secondary outcomes (2)
analgésia consumption
time to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startSep 2006
- Study completionDec 2006
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lasse Andersen, M.D., Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408707
- Sponsor's protocol ID
- KF01320120
- Status last verified
- Feb 2008
- First submitted
- 6 Dec 2006
- Last updated
- 29 Feb 2008
- Results posted
- No
Publications
Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.
PubMed 19025523
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty: a Placebo Controlled, Randomized, Double-Blinded Study.
- ClinicalTrials.gov ID
- NCT00408707
- Acronym / sponsor ID
- KF01320120
- Conditions
- Postoperative Pain
- Keywords
- local infiltration analgesia, postoperative pain, ropivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 7 Dec 2006 (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 this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after total knee arthroplasty.
Detailed description
Total knee arthroplasty (TKA) is increasingly common in the treatment of osteoarthrosis. Despite aggressive analgesic regimes, TKA is associated with moderate to severe postoperative pain, delaying mobilization and hospital discharge. A relatively new method for controlling postoperative pain after TKA is local infiltration analgesia (LIA) which consists of local infiltration with Ropivacaine and adrenaline.3 studies haved showed promising results of LIA, but none have documented a superior analgesic effect versus placebo.Patients receiving bilateral knee arthroplasty are recruited to receive LIA and placebo infiltration.The aim of the study is to demonstrate an analgesic effect of LIA versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients eligible for total knee arthroplasty
- must speak and understand Danish
- must be able to give oral and written consent
Key exclusion criteria (4 listed)
- Alcohol or medicine abuse
- Treatment with opioids
- Allergy to local anaesthetics
- Severe obesity
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 |
|---|---|---|
| local infiltration analgesia | Procedure or surgery | – |
Primary outcome
Postoperative pain
2 secondary outcomes
analgésia consumption
time to discharge
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 29 Feb 2008.
- Derived from this study: PubMed 19025523Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.
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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.
Lasse Andersen, 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?
A Phase 4 study testing local infiltration analgesia in people with Postoperative Pain, 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 4 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 29 Feb 2008. 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.
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. 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 NCT00408707, 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 29 Feb 2008.