Fast Track TKA: LIA vs FNB

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Sint Maartenskliniek
Sponsor:
Information provided by (Responsible Party):
Rudolf Stienstra, Sint Maartenskliniek
ClinicalTrials.gov Identifier:
NCT01966263
First received: October 11, 2013
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Arthroplasty, Replacement, 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
Procedure: FNB with catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block

Resource links provided by NLM:


Further study details as provided by Sint Maartenskliniek:

Primary Outcome Measures:
  • Performance Battery consisting of three functional tests [ Time Frame: one year ] [ Designated as safety issue: No ]
    The performance battery consists of three functional tests: The Timed Up and Go test (TUG), the Stair Climbing Task (SCT) and the Six Minutes Walk Test (6MWT).


Secondary Outcome Measures:
  • length of stay [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]
    duration of hospitalization after the total knee arthroplasty

  • time to reach discharge criteria [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]
    tiem to reach discharge criteria after total knee arthroplasty (in days)

  • quantity of mobilization during hospitalization [ Time Frame: 3-7 days ] [ Designated as safety issue: No ]
    quantity of mobilization (walking, standing, stair climbing etc) in hours, during hospitalization

  • pain medication consumption [ Time Frame: during hospital stay; 3, 6 and 12 months postoperatively ] [ Designated as safety issue: No ]
    consumption of pain medication

  • painscores [ Time Frame: during hospital stay; 3, 6 and 12 months postoperatively ] [ Designated as safety issue: No ]
    painscores at rest and during mobilization

  • range of motion [ Time Frame: at hospital discharge (3-7 days postoperative); 3, 6 and 12 months postoperatively ] [ Designated as safety issue: No ]
    range of motion of the operated knee

  • functional outcome [ Time Frame: at hospital discharge (3-7 days postoperative); 6 weeks, 3, 6 and 12 months postoperatively ] [ Designated as safety issue: No ]
    functional outcome reported by the patient (patient-based questionnaires)

  • fear of motion [ Time Frame: at hospital discharge (3-7 days postoperative), 6 weeks, 3, 6 and 12 months postoperatively ] [ Designated as safety issue: No ]
    fear of motion reported by the patient (questionnaire)

  • quality of life [ Time Frame: at hospital discharge(3-7 days postoperative), 6 weeks, 3, 6 and 12 months postoepratively ] [ Designated as safety issue: No ]
    quality of life by patient-based questionnaire

  • patient satisfaction (Numeric Rating Scale; 0=very dissatisfied, 10=very satisfied) [ Time Frame: at hospital discharge (3-7 days postoperative) ] [ Designated as safety issue: No ]
    patient satisfaction (NRS) with analgesia and patient satisfaction (NRS) with fast track rehabilitation protocol


Estimated Enrollment: 80
Study Start Date: November 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 analgesie (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 analgesie (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 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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966263

Contacts
Contact: Rudolf Stienstra, MD, PhD +31 (0)24 365 9085 r.stienstra@maartenskliniek.nl
Contact: Maaike Fenten, MD +31 (0)24 365 9935 m.fenten@maartenskliniek.nl

Locations
Netherlands
Sint Maartenskliniek Not yet recruiting
Ubbergen, Netherlands, 6574NA
Contact: Rudolf Stienstra, MD, PhD    +31 (0)24 365 9085    r.stienstra@maartenskliniek.nl   
Contact: Maaike Fenten, MD    +31 (0)24 365 9935    m.fenten@maartenskliniek.nl   
Sponsors and Collaborators
Sint Maartenskliniek
Investigators
Principal Investigator: Rudolf Stienstra, MD, PhD Sint Maartenskliniek
  More Information

No publications provided

Responsible Party: Rudolf Stienstra, Anesthesiologist, Head of anesthesiology department, Sint Maartenskliniek
ClinicalTrials.gov Identifier: NCT01966263     History of Changes
Other Study ID Numbers: 497, 2013-001008-13, NL43965.072.13
Study First Received: October 11, 2013
Last Updated: October 16, 2013
Health Authority: the Netherlands: Central Committee on Research inv. Human Subjects

Keywords provided by Sint Maartenskliniek:
total knee arthroplasty
femoral nerve block
local infiltration analgesia
fast track

Additional relevant MeSH terms:
Anesthetics, Local
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014