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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Pain

Intervention / Treatment
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* Combination Product: lidocaine and ropivacaine injection through catheters


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: six-hole group<br>lidocaine and ropivacaine injection through catheters | Combination Product: lidocaine and ropivacaine injection through catheters<br>* 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.<br>|
| Active Comparator: end-hole group<br>lidocaine and ropivacaine injection through catheters | Combination Product: lidocaine and ropivacaine injection through catheters<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total LA consumption at 24h | total ropivacaine consumption at 24h in mL | 24h after connecting PCA to the femoral nerve catheter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total LA consumption at 48h | total ropivacaine consumption at 48h in mL | 48h after connecting PCA to the femoral nerve catheter | 
| number of boluses of ropivacaine at 24h | total ropivacaine boluses received at 24h in numbers | 24h after connecting PCA to the femoral nerve catheter | 
| number of boluses of ropivacaine at 48 h | total ropivacaine boluses received at 48h in numbers | 48h after connecting PCA to the femoral nerve catheter | 
| quadriceps strength before surgery and 24h and 48h after surgery | quadriceps strength measured with with an electronic dynamometer in N.m and percentage of preblock value of MVIC | quadriceps strenght before performing femoral nerve block and 24 and 48h after performing the block | 
| morphine requirements at 24h and 48h | rescue morphine 24h and 48h in mg | morphine consumption at 24h and 48h after completion of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiorifice or endhole femoral nerve catheter