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Stimulating Catheter for Lumbar Plexus

A

ASST Gaetano Pini-CTO

Status and phase

Completed
Phase 4

Conditions

Knee Arthritis Disease

Treatments

Device: stimulong 100, pajunk, germany
Device: plexolong 100, pajunk, germany

Study type

Interventional

Funder types

Other

Identifiers

NCT01978275
IOGPGC02-13

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients undergoing total knee arthroplasty

Exclusion criteria

  • diabetes
  • coagulation disorders
  • allergy to local anesthetic

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

58 participants in 2 patient groups

stimulating catheters group
Experimental group
Description:
Lumbar plexus block performed through stimulating catheter
Treatment:
Device: stimulong 100, pajunk, germany
nonstimulating catheters
Active Comparator group
Description:
lumbar plexus block through nonstimulating catheters
Treatment:
Device: plexolong 100, pajunk, germany

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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