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Completed

NCT Number: NCT01966263

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Knee

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sint Maartenskliniek

Ubbergen, 6574NA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIA of the posterior capsule of the knee

Procedure

the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.

Other names: Naropin 0.2%, Adrenalin 1mg/mL, local infiltration analgesia

LIA of the anterior capsule of the knee

Procedure

the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.

Other names: Naropin 0.2%, Adrenalin 1mg/mL, local infiltration analgesia

LIA of the subcutaneous tissue of the knee

Procedure

the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.

Other names: Naropin 0.2%, local infiltration analgesia

FNB with catheter

Procedure

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

Other names: Naropin 0.2%, normal saline, femoral nerve block, continuous femoral nerve block, femoral catheter

Primary outcomes

  1. Stair Climbing Task (SCT)

    Time frame: 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 outcomes

  1. Timed Up and Go Test (TUG)

    Time frame: 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.

  2. Six Minute Walking Test (6MWT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Oct 21, 2013
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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