Bacterial Colonization After Tunneling in Femoral Perineural Catheters

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01016925

Acronym

Tunnelized KT

Enrollment

338

Registered

2009-11-20

Start date

2009-12-01

Completion date

2011-12-01

Last updated

2026-05-12

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

Conditions

Bacterial Colonization

Keywords

femoral perineural catheter, tunnelization, complication, colonization, infection

Brief summary

Background: Bacterial colonization of peripheral nerve catheters is frequent, although infection is relatively rare. With central venous catheters, the tunneling of catheter into the subcutaneous tissue significantly decreases catheter colonization and catheter-related sepsis. Purpose: The aim of this study is to evaluate the incidence of bacterial colonization in adult patients with femoral tunnelized perineural nerve catheters. Methods: A total of 338 patients with femoral catheter will be included in the study. The patients will be randomized to be included in the control group (without tunnelling) or in the group with catheter tunneled 2-3 cm subcutaneously. After removal, catheter will be analyzed for colonization (primary outcome). Quantitative culture will be used as described by Brun-Buisson for intravascular catheters. The site of insertion will be monitored daily for any signs of infection (secondary outcome). Perspective: To show the incidence of femoral perineural catheter colonization is low with subcutaneous tunneling

Interventions

PROCEDUREtunnelized perineural catheter

the catheter will be tunneled 2-3 cm subcutaneously.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients scheduled to undergo scheduled orthopaedic surgery performed with a femoral perineural catheter

Exclusion criteria

* Age under 18 years * Local nerve pathology * Refusal to regional anaesthesia * Major psychological disorder * Major cardiac conduction disease * Infection at the puncture site

Design outcomes

Primary

Measure	Time frame
incidence of femoral perineural catheter colonization	between 24 hours and 72 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026