Local Infiltration Analgesia During Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Local Infiltration Analgesia During Total Knee Arthroplasty - Reduced Opiate Consumption and Faster Mobilisation Postoperatively - Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline
* Other: saline injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring primary TKA for primary OA Patients aged 75 years or less Patients suitable for all applicable devices Exclusion Criteria: Rheumatoid arthritis or other inflammatory diseases Patients requiring bone grafting during surgery Unwilling to provide informed consent BMI > 35 ASA > 3 Renal dysfunction 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: local infiltration analgesia<br>The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline | Drug: The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline<br>* The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline<br>|
| Placebo Comparator: saline injection<br>The normal saline injection are used in the control group in the same manner than in the RKA group. | Other: saline injection<br>* saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxycodone consumption during the first 48 postoperative hours |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome after TKA |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain relief