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Stimulating Catheter for Lumbar Plexus

Are Stimulating Catheters More Efficacy for Lumbar Plexus Block Compared With Traditional Non-stimulating Ones? A Randomized, Prospective, Blinded, up and Down Study.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01978275
Enrollment
58
Registered
2013-11-07
Start date
2013-04-30
Completion date
2013-12-31
Last updated
2014-02-17

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

Conditions

Knee Arthritis Disease

Keywords

total knee arthroplasty, lumbar plexus block, stimulating catheters, peripheral nerve blocks

Brief summary

Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. Furthermore no volume-response study has compared the success rates of the two techniques for continuous lumbar plexus block. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters decrease the minimal effective volume (MEAV) of 1.5% mepivacaine required for successful lumbar plexus block (LPB) in 50% of patients compared with conventional non-stimulating catheters.

Interventions

DEVICEstimulong 100, pajunk, germany

simulating catheter

DEVICEplexolong 100, pajunk, germany

nonstimulating catheter

Sponsors

ASST Gaetano Pini-CTO
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

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

Inclusion criteria

* patients undergoing total knee arthroplasty

Exclusion criteria

* diabetes * coagulation disorders * allergy to local anesthetic

Design outcomes

Primary

MeasureTime frame
minimum effective anesthetic volume in 50% of patientsthirty minutes after local anesthetic injection

Secondary

MeasureTime frame
morphine requirementintraoperatively

Countries

Italy

Outcome results

None listed

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