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

University Hospitals (UH)

Status: Completed

Conditions: Pain

Treatments: Combination Product: lidocaine and ropivacaine injection through catheters

Study type: Interventional

Funder types: Other

Identifiers

NCT03376178

FROXANE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

six-hole group

Experimental group

Description:

lidocaine and ropivacaine injection through catheters

Treatment:

Combination Product: lidocaine and ropivacaine injection through catheters

end-hole group

Active Comparator group

Description:

lidocaine and ropivacaine injection through catheters

Treatment:

Combination Product: lidocaine and ropivacaine injection through catheters