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

Sint Maartenskliniek

Status and phase: Completed; Phase 4

Conditions: Arthroplasty, Replacement, Knee

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01966263

NL43965.072.13 (Other Identifier)

2013-001008-13 (EudraCT Number)

497

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Local Infiltration Analgesia (LIA)

Active Comparator group

Description:

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

Treatment:

Procedure: LIA of the subcutaneous tissue of the knee

Procedure: LIA of the posterior capsule of the knee

Procedure: LIA of the anterior capsule of the knee

Femoral Nerve Block (FNB)

Active Comparator group

Description:

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

Treatment:

Procedure: FNB with catheter

Procedure: LIA of the posterior capsule of the knee