Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block

Study Overview
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Brief Summary
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The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.

Detailed Description
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For an optimal and fast recovery after total knee arthroplasty (TKA), a fast track rehabilitation protocol has been developed. The literature is not yet conclusive about the optimal anesthestic technique. The optimal technique should support fast mobilization by giving good pain relieve with minimal side effects such as nausea, drowsiness and muscle weakness. If pain relieve is optimal, the patient mobilizes fast and length of stay is shortened. But does fast recovery lead to better functional outcome? The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.

Official Title
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Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Procedure: LIA of the posterior capsule of the knee
* Procedure: LIA of the anterior capsule of the knee
* Procedure: LIA of the subcutaneous tissue of the knee
* Procedure: FNB with catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical health status I-II patient presents with non-inflammatory primary knee osteoarthritis (radiological confirmation) patient is planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS) patient is scheduled for fast track protocol patient plans to be available fot follow-up through one year post-operative written informed consent Exclusion Criteria: any contra-indication for locoregional anesthesia any contra-indication for spinal anesthesia traumatic osteoarthritis requiring TKA an active, local infection or systemic infection known hypersensitivity to amide-type local anesthetics known intolerance or contraindication for opioids, nonsteroidal antiinflammatory drugs (NSAIDs) or paracetamol a Body Mass Index > 40 kg/m2 inability to walk independently (inability to walk at least 10 consecutive meters without a walking aid) scheduled for contralateral TKA within one year postoperative scheduled for another operation within 3 months postoperative physical, emotional or neurological conditions that would compromize compliance with postoperative rehabilitation and follow-up chronic opioid analgesic therapy chronic gabapentin or pregabalin analgesic therapy rheumatoid arthritis

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local Infiltration Analgesia (LIA)<br>local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee | Procedure: LIA of the posterior capsule of the knee<br>* the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.<br>* Other names: local infiltration analgesia;Procedure: LIA of the anterior capsule of the knee<br>* the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.<br>* Other names: local infiltration analgesia;Procedure: LIA of the subcutaneous tissue of the knee<br>* the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.<br>* Other names: local infiltration analgesia;|
| Active Comparator: Femoral Nerve Block (FNB)<br>a femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve. In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee | Procedure: LIA of the posterior capsule of the knee<br>* the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.<br>* Other names: local infiltration analgesia;Procedure: FNB with catheter<br>* pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours<br>* Other names: femoral catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stair Climbing Task (SCT) | The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go Test (TUG) | The TUG assesses basic mobility skill as well as strength, balance, and agility. Originally developed for frail elderly people as the Get-Up and Go Test in 1986, it was adapted in 1991 to include the time component. The TUG is used in a range of populations from children to the elderly and for many conditions, including osteoarthritis, joint arthroplasty, rheumatoid arthritis, hip fractures, stroke, vertigo, and cerebral palsy. | 1 year | 
| Six Minute Walking Test (6MWT) | The 6MWT assesses endurance and ability to walk over longer distances. The 6MWT was first described as a field test for physical fitness in 1963 and then as a 12-minute walk test in people with chronic bronchitis. The 6MWT was found to perform as well as the 12-minute walk, and is now used to assess the submaximal level of functional performance at a similar level required for daily physical activities. Used in many conditions, such as osteoarthritis, cardiopulmonary disease, stroke, traumatic brain injury, patients who have undergone an amputation, Parkinson's disease, and Alzheimer's disease, as well as in elderly populations and children. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, femoral nerve block, local infiltration analgesia, fast track