Phase 4 N=80 Randomized Single-blind Treatment

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

Arthroplasty, Replacement, Knee

Bottom Line

View on ClinicalTrials.gov: NCT01966263 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcome: Primary: Stair Climbing Task (SCT) — 14.3; 13.8 seconds

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 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 (Procedure)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Sint Maartenskliniek
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Stair Climbing Task (SCT)	14.3; 13.8	—
SECONDARY Timed Up and Go Test (TUG)	7.8; 7.6	—
SECONDARY Six Minute Walking Test (6MWT)	489; 505	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01966263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.