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

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

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Procedure: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Ubbergen, Netherlands, 6574NA
    • Sint Maartenskliniek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local Infiltration Analgesia (LIA); 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	Procedure: LIA of the posterior capsule of the knee; 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; Procedure: LIA of the anterior capsule of the knee; 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; Procedure: LIA of the subcutaneous tissue of the knee; 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
Active Comparator: Femoral Nerve Block (FNB); 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	Procedure: LIA of the posterior capsule of the knee; 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; Procedure: FNB with catheter; 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: normal saline; Naropin 0.2%; femoral nerve block; continuous femoral nerve block; femoral catheter

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go Test (TUG)	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.	1 year
Six Minute Walking Test (6MWT)	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.	1 year

Collaborators and Investigators

• Sponsor: Sint Maartenskliniek
• Investigators: Principal Investigator: Rudolf Stienstra, MD, PhD, Sint Maartenskliniek

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 11, 2013
• First Submitted That Met QC Criteria: October 16, 2013
• First Posted (Estimate): October 21, 2013

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: total knee arthroplasty; femoral nerve block; local infiltration analgesia; fast track
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ropivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 497; 2013-001008-13 (EudraCT Number); NL43965.072.13 (Other Identifier: CCMO register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No