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Stimulating Catheter for Lumbar Plexus

NCT ID: NCT01978275

Last Updated: 2014-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Arthritis Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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stimulating catheters group

Lumbar plexus block performed through stimulating catheter

Group Type EXPERIMENTAL

stimulong 100, pajunk, germany

Intervention Type DEVICE

simulating catheter

nonstimulating catheters

lumbar plexus block through nonstimulating catheters

Group Type ACTIVE_COMPARATOR

plexolong 100, pajunk, germany

Intervention Type DEVICE

nonstimulating catheter

Interventions

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stimulong 100, pajunk, germany

simulating catheter

Intervention Type DEVICE

plexolong 100, pajunk, germany

nonstimulating catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing total knee arthroplasty

Exclusion Criteria

* diabetes
* coagulation disorders
* allergy to local anesthetic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ASST Gaetano Pini-CTO

OTHER

Sponsor Role lead

Responsible Party

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Gianluca Cappelleri

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istituto Ortopedico G. Pini

Milan, Milano, Italy

Site Status

Countries

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Italy

Other Identifiers

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IOGPGC02-13

Identifier Type: -

Identifier Source: org_study_id

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