Postoperative PainNCT00518674
Local Anesthetics After Total Knee Arthroplasty
A study testing local infiltration analgesia in people with Postoperative Pain, run by Hvidovre University Hospital.
Trial summary
The aim of this randomized, double-blind and placebo-controlled study is to evaluate the specific role of injection of local anesthetic into the intra- vs. extraarticular tissues after toal knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- local infiltration analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Sep 2007
- Phase
- Interventional
- 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
- Able to give informed oral and written consent to participate
- Able to speak Danish
Who cannot join
- Treatment with opioids
- Body Mass Index > 40
About this study
Official title: Local Anesthetics After Total Knee Arthroplasty: Intra- vs. Extraarticular Administration? A Randomized, Double-Blind, Placebo-Controlled Study
The aim of this randomized, double-blind and placebo-controlled study is to evaluate the specific role of injection of local anesthetic into the intra- vs. extraarticular tissues after toal knee arthroplasty.
- Conditions
- Postoperative Pain
- Being tested
- local infiltration analgesia
- Keywords
- pain, local infiltration analgesia
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local infiltration analgesiaProcedure or surgery
local wound infiltration with 30 ml ropivacaine 0.2 % (60 mg)
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale pain score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startJan 2007
- Study completionSep 2007 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lasse Andersen, MD, Principal investigator, Hvidovre University Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518674
- Sponsor's protocol ID
- KF01329190
- Status last verified
- Jul 2007
- First submitted
- 20 Aug 2007
- Last updated
- 21 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersen LO, Kristensen BB, Madsen JL, Otte KS, Husted H, Kehlet H. Wound spread of radiolabeled saline with multi- versus few-hole catheters. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):200-2. doi: 10.1097/aap.0b013e3181c7733d.
PubMed 20301825
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthetics After Total Knee Arthroplasty: Intra- vs. Extraarticular Administration? A Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00518674
- Acronym / sponsor ID
- KF01329190
- Conditions
- Postoperative Pain
- Keywords
- pain, local infiltration analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Sep 2007 (estimated)
- First posted
- 21 Aug 2007 (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 aim of this randomized, double-blind and placebo-controlled study is to evaluate the specific role of injection of local anesthetic into the intra- vs. extraarticular tissues after toal knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to give informed oral and written consent to participate
- Able to speak Danish
Key exclusion criteria (2 listed)
- Treatment with opioids
- Body Mass Index > 40
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 analgesialocal wound infiltration with 30 ml ropivacaine 0.2 % (60 mg) | Procedure or surgery | – |
Primary outcome
Visual Analogue Scale pain score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2007.
- Derived from this study: PubMed 20301825Andersen LO, Kristensen BB, Madsen JL, Otte KS, Husted H, Kehlet H. Wound spread of radiolabeled saline with multi- versus few-hole catheters. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):200-2. doi: 10.1097/aap.0b013e3181c7733d.
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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, MD principal investigator
Hvidovre University Hospital, Copenhagen, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing local infiltration analgesia in people with Postoperative Pain, run by Hvidovre University Hospital.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Visual Analogue Scale pain score. 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 NCT00518674, 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 21 Aug 2007.