Skip to content

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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03376178
Enrollment
72
Registered
2017-12-18
Start date
2014-05-31
Completion date
2015-04-30
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

multiorifice or endhole femoral nerve catheter

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.

Interventions

COMBINATION_PRODUCTlidocaine 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.

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
total LA consumption at 24h24h after connecting PCA to the femoral nerve cathetertotal ropivacaine consumption at 24h in mL

Secondary

MeasureTime frameDescription
morphine requirements at 24h and 48hmorphine consumption at 24h and 48h after completion of surgeryrescue morphine 24h and 48h in mg
total LA consumption at 48h48h after connecting PCA to the femoral nerve cathetertotal ropivacaine consumption at 48h in mL
number of boluses of ropivacaine at 24h24h after connecting PCA to the femoral nerve cathetertotal ropivacaine boluses received at 24h in numbers
number of boluses of ropivacaine at 48 h48h after connecting PCA to the femoral nerve cathetertotal ropivacaine boluses received at 48h in numbers
quadriceps strength before surgery and 24h and 48h after surgeryquadriceps strenght before performing femoral nerve block and 24 and 48h after performing the blockquadriceps strength measured with with an electronic dynamometer in N.m and percentage of preblock value of MVIC

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026