Clinical trial NCT01966263: Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block
Official title: Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Knee
Keywords: total knee arthroplasty
femoral nerve block
local infiltration analgesia
fast track
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stair Climbing Task (SCT)
timeFrame: one year
Secondary outcomes:
measure: Timed Up and Go Test (TUG)
timeFrame: 1 year
measure: Six Minute Walking Test (6MWT)
timeFrame: 1 year
Other outcomes:
Locations:
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
Study officials:
affiliation: Sint Maartenskliniek
name: Rudolf Stienstra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fenten MGE, Bakker SMK, Scheffer GJ, Wymenga AB, Stienstra R, Heesterbeek PJC. Femoral nerve catheter vs local infiltration for analgesia in fast track total knee arthroplasty: short-term and long-term outcomes. Br J Anaesth. 2018 Oct;121(4):850-858. doi: 10.1016/j.bja.2018.05.069. Epub 2018 Jul 26.