PainLIANCT01305733
Local Infiltration Analgesia During Total Knee Arthroplasty
A study testing The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline and saline injection in people with Pain, run by Coxa, Hospital for Joint Replacement at 2 sites in Finland.
Trial summary
The primary objective is to evaluate whether local infiltration analgesia (LIA) will reduce oxycodone consumption during the first 48 postoperative hours in patients undergoing total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline and saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFinland
- Study dates
- Mar 2011to Dec 2012
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring primary TKA for primary OA
- Patients aged 75 years or less
- Patients suitable for all applicable devices
Who cannot join
- Rheumatoid arthritis or other inflammatory diseases
- Patients requiring bone grafting during surgery
- Unwilling to provide informed consent
- BMI > 35
- ASA > 3
- Renal dysfunction
Show all 11Show fewer
- Allergic to ASA
- Previous high tibial osteotomy or previous osteosynthesis
- > 15 degrees varus / valgus malalignment
- Physical, emotional or neurological conditions which would comprise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)
- Known sensitivity to materials in the devices
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Coxa - hospital for joint replacement
Tampere, Pirkanmaa, 33560
COXA
Tampere, Pirkanmaa, 33560
About this study
Official title: Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial
The primary objective is to evaluate whether local infiltration analgesia (LIA) will reduce oxycodone consumption during the first 48 postoperative hours in patients undergoing total knee arthroplasty (TKA).
Read the detailed description
The goal of LIA is to gain an effective and safe pain control during the first postoperative days. The study is a single-center, randomized controlled trial, which will be performed in Coxa Hospital for Joint Replacement in Tampere, Finland. The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline with occasional variations if the patient is unusually small, very elderly, infirm or has a history of significant intolerance to analgesics or anesthetic agents. The RKA mixture is diluted with normal saline. Total volume of the solution is 100 ml depending on the size of the wound. The normal saline injection are used in the control group in the same manner than in the RKA group.
- Conditions
- Pain
- Being tested
- The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline, saline injection
- Keywords
- Pain relief
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenalineDrug
The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline
saline injectionOther
saline
| Study group | Role | What they receive |
|---|---|---|
| local infiltration analgesia | Active comparator | The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline Receives: Drug: The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline |
| saline injection | Placebo comparator | The normal saline injection are used in the control group in the same manner than in the RKA group. Receives: Other: saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxycodone consumption during the first 48 postoperative hours
Measured: 48 hours
Secondary outcomes (1)
functional outcome after TKA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coxa, Hospital for Joint Replacement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mika Niemeläinen, Coxa, Hospital for Joint Replacement
- Investigators
- Antti Eskelinen, M.D., Ph.D, Study director, Coxa, Hospital for Joint ReplacementMika Niemeläinen, MD, Principal investigator, Coxa, Hospital for Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305733
- Sponsor's protocol ID
- Coxa - LIA
- Acronym
- LIA
- Status last verified
- May 2012
- First submitted
- 28 Feb 2011
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01305733
- Acronym / sponsor ID
- LIA / Coxa - LIA
- Conditions
- Pain
- Keywords
- Pain relief
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Coxa, Hospital for Joint ReplacementUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 1 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.
The primary objective is to evaluate whether local infiltration analgesia (LIA) will reduce oxycodone consumption during the first 48 postoperative hours in patients undergoing total knee arthroplasty (TKA).
Detailed description
The goal of LIA is to gain an effective and safe pain control during the first postoperative days. The study is a single-center, randomized controlled trial, which will be performed in Coxa Hospital for Joint Replacement in Tampere, Finland. The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline with occasional variations if the patient is unusually small, very elderly, infirm or has a history of significant intolerance to analgesics or anesthetic agents. The RKA mixture is diluted with normal saline. Total volume of the solution is 100 ml depending on the size of the wound. The normal saline injection are used in the control group in the same manner than in the RKA group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local infiltration analgesia | Active comparator | Drug: The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenalineThe injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline |
| saline injection | Placebo comparator | Other: saline injectionThe normal saline injection are used in the control group in the same manner than in the RKA group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring primary TKA for primary OA
- Patients aged 75 years or less
- Patients suitable for all applicable devices
Key exclusion criteria (11 listed)
- Rheumatoid arthritis or other inflammatory diseases
- Patients requiring bone grafting during surgery
- Unwilling to provide informed consent
- BMI > 35
- ASA > 3
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 |
|---|---|---|
| The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenalineThe injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline | Drug | local infiltration analgesia |
| saline injectionsaline | Other | saline injection |
Primary outcome
oxycodone consumption during the first 48 postoperative hours
Time frame: 48 hours
1 secondary outcome
functional outcome after TKA
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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.
Antti Eskelinen, M.D., Ph.D study director
Coxa, Hospital for Joint Replacement
Mika Niemeläinen, MD principal investigator
Coxa, Hospital for Joint Replacement
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline and saline injection in people with Pain, run by Coxa, Hospital for Joint Replacement at 2 sites in Finland.
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 11 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 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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. Some participants in this study may receive a placebo. 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?
oxycodone consumption during the first 48 postoperative hours (time frame: 48 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 9 May 2012.