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Completed

NCT Number: NCT03376178

Catheter Orifice Configuration (Six-hole Versus End-hole) on Post-operative Analgesia After Total Knee Arthroplasty.

Multiorifice catheters have been shown to provide superior analgesia and significantly reduce local anesthetic consumption compared with end-hole catheters in epidural studies. This prospective, blinded, randomized study tested the hypothesis that, in continuous femoral nerve block (CFNB) under ultrasound guidance, multiorifice catheter would reduce local anesthetic consumption at 24h compared with end-hole catheter.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospitals of Geneva

Geneva, 1211, Switzerland

About this study

Eighty adult patients (aged ≥18 years) scheduled to undergo primary total knee arthroplasty under a combination of continuous femoral nerve block (CFNB), sciatic nerve block and general anesthesia were randomized to CFNB using either a 3-pair micro-hole (Contiplex, BRAUN®, 20G - 400 mm) or an end-hole (Silverstim VYGON®, 20G - 500 mm) catheter. Once the femoral catheter was sited, a bolus of 20 mL lidocaine 1% was injected. An electronic pump then delivered an automated 5 mL bolus of ropivacaine 0.2% hourly, with 10 mL self-administered patient controlled analgesia boluses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • every patient accepting a conitnuous femoral nerve catheter

Exclusion criteria

  • pregnancy,
  • any contraindication to peripheral nerve blockade,
  • pre-existing peripheral nerve neuropathy,
  • allergy to LA (study medications),
  • ASA score ≥4,
  • neurologic or neuromuscular disease,
  • psychiatric disease,
  • renal failure,
  • hepatic failure,
  • chronic opioid therapy,
  • NSAID contraindication,
  • inability to use a patient controlled analgesia (PCA) device, g
  • enu valgum,
  • infection at the injection site or
  • withdrawal of consent.

Treatment and study plan

lidocaine and ropivacaine injection through catheters

Combination Product

injection of local anesthetic through an endhole or a sixhole femoral nerve catheter in the context of total knee replacement. Analgesic properties at 24 and 48h of both groups registered.

Primary outcomes

  1. total LA consumption at 24h

    Time frame: 24h after connecting PCA to the femoral nerve catheter

    total ropivacaine consumption at 24h in mL

Secondary outcomes

  1. total LA consumption at 48h

    Time frame: 48h after connecting PCA to the femoral nerve catheter

    total ropivacaine consumption at 48h in mL

  2. number of boluses of ropivacaine at 24h

    Time frame: 24h after connecting PCA to the femoral nerve catheter

    total ropivacaine boluses received at 24h in numbers

  3. number of boluses of ropivacaine at 48 h

    Time frame: 48h after connecting PCA to the femoral nerve catheter

    total ropivacaine boluses received at 48h in numbers

  4. quadriceps strength before surgery and 24h and 48h after surgery

    Time frame: quadriceps strenght before performing femoral nerve block and 24 and 48h after performing the block

    quadriceps strength measured with with an electronic dynamometer in N.m and percentage of preblock value of MVIC

  5. morphine requirements at 24h and 48h

    Time frame: morphine consumption at 24h and 48h after completion of surgery

    rescue morphine 24h and 48h in mg

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Ultrasound-guided Continuous Femoral Nerve Block: The Influence of Catheter Orifice Configuration (Six-hole Versus End-hole) on Post-operative Analgesia After Total Knee Arthroplasty. A Randomized Trial.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 18, 2017
Registry last updated
Dec 18, 2017

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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