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

NCT01966263 | Completed Phase 4 Results

• 3 other identifiers: 4972013-001008-13NL43965.072.13
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee

Keywords

total knee arthroplasty; femoral nerve block; local infiltration analgesia; fast track

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Timed Up and Go Test (TUG)

  1 year

• Six Minute Walking Test (6MWT)

  1 year

Study Arms (2)

Local Infiltration Analgesia (LIA)

ACTIVE COMPARATOR

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; Procedure: LIA of the anterior capsule of the knee; Procedure: LIA of the subcutaneous tissue of the knee

Femoral Nerve Block (FNB)

ACTIVE COMPARATOR

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; Procedure: FNB with catheter

Interventions

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.

Also known as: Naropin 0.2%, Adrenalin 1mg/mL, local infiltration analgesia

Femoral Nerve Block (FNB); Local Infiltration Analgesia (LIA)

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.

Also known as: Naropin 0.2%, Adrenalin 1mg/mL, local infiltration analgesia

Local Infiltration Analgesia (LIA)

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.

Also known as: Naropin 0.2%, local infiltration analgesia

Local Infiltration Analgesia (LIA)

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

Also known as: Naropin 0.2%, normal saline, femoral nerve block, continuous femoral nerve block, femoral catheter

Femoral Nerve Block (FNB)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sint Maartenskliniek: lead

Study Sites (1)

Sint Maartenskliniek

Ubbergen, 6574NA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 30236246 DERIVED

MeSH Terms

Interventions

Epinephrine; Catheters; Saline Solution

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Equipment and Supplies; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr Maaike Fenten
• Organization: Sint Maartenskliniek Nijmegen

m.fenten@maartenskliniek.nl

31243659111

Study Officials

• Rudolf Stienstra, MD, PhD

  Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Head of anesthesiology department

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 21, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2015
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)