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

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ClinicalTrials.gov Identifier: NCT03376178
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Pain Combination Product: lidocaine and ropivacaine injection through catheters

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eighty adult patients (aged ≥18 years) scheduled to undergo primary total knee arthroplasty under a combination of 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: All investigators, patients, and other clinical staff were blinded to the treatment group. The investigator in charge of the patient was unaware of patient allocation. He did not perform the block or open the sealed and opaque envelope, but followed the patient in the ward. An opaque skin dressing was used in order to blind the type of catheter used. End-hole catheter Vygon is white and stiff whereas six-hole catheter contiplex is yellow and flexible.
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : May 2014
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: six-hole group
lidocaine and ropivacaine injection through catheters
Combination Product: lidocaine and ropivacaine injection through catheters
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.
Active Comparator: end-hole group
lidocaine and ropivacaine injection through catheters
Combination Product: lidocaine and ropivacaine injection through catheters
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376178


Locations
Switzerland
University hospitals of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Study Director: Martin Tramer Anesthesiology department Of University Hospital of Geneva
More Information

Publications:

Responsible Party: FOURNIER ROXANE, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03376178     History of Changes
Other Study ID Numbers: FROXANE
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by FOURNIER ROXANE, University Hospital, Geneva:
multiorifice or endhole femoral nerve catheter

Additional relevant MeSH terms:
Lidocaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action