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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Combination Product: lidocaine and ropivacaine injection through catheters

• Registration Number: NCT03376178
• Lead Sponsor: University Hospital, Geneva

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.

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 Timeline

• Study Start: 2014-05
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2017-12
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Last Update Submitted: 2017-12-12
• Study First Posted: 2017-12-18
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
end-hole group	lidocaine and ropivacaine injection through catheters	lidocaine and ropivacaine injection through catheters
six-hole group	lidocaine and ropivacaine injection through catheters	lidocaine and ropivacaine injection through catheters

Primary Outcome Measures

Name	Time	Method
total LA consumption at 24h	24h after connecting PCA to the femoral nerve catheter	total ropivacaine consumption at 24h in mL

Secondary Outcome Measures

Name	Time	Method
total LA consumption at 48h	48h after connecting PCA to the femoral nerve catheter	total ropivacaine consumption at 48h in mL
number of boluses of ropivacaine at 24h	24h after connecting PCA to the femoral nerve catheter	total ropivacaine boluses received at 24h in numbers
number of boluses of ropivacaine at 48 h	48h after connecting PCA to the femoral nerve catheter	total ropivacaine boluses received at 48h in numbers
quadriceps strength before surgery and 24h and 48h after surgery	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
morphine requirements at 24h and 48h	morphine consumption at 24h and 48h after completion of surgery	rescue morphine 24h and 48h in mg

Trial Locations

Locations (1)

University hospitals of Geneva; 🇨🇭 Geneva, Switzerland