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

Phase 4

Completed

Conditions: Arthroplasty, Replacement, Knee

Interventions: Procedure: LIA of the posterior capsule of the knee
Procedure: FNB with catheter
Procedure: LIA of the anterior capsule of the knee
Procedure: LIA of the subcutaneous tissue of the knee

Registration Number: NCT01966263

Lead Sponsor: Sint Maartenskliniek

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Infiltration Analgesia (LIA)	LIA of the posterior capsule of the knee	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
Femoral Nerve Block (FNB)	FNB with catheter	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
Local Infiltration Analgesia (LIA)	LIA of the anterior capsule of the knee	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
Femoral Nerve Block (FNB)	LIA of the posterior capsule of the knee	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
Local Infiltration Analgesia (LIA)	LIA of the subcutaneous tissue of the knee	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

Primary Outcome Measures

Name	Time	Method
Stair Climbing Task (SCT)	one year	The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.

Secondary Outcome Measures

Name	Time	Method
Timed Up and Go Test (TUG)	1 year	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.
Six Minute Walking Test (6MWT)	1 year	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.