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Completed

NCT Number: NCT01978275

Stimulating Catheter for Lumbar Plexus

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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Key information

Conditions

Knee Arthritis Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istituto Ortopedico G. Pini

Milan, Milano, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing total knee arthroplasty

Exclusion criteria

  • diabetes
  • coagulation disorders
  • allergy to local anesthetic

Treatment and study plan

stimulong 100, pajunk, germany

Device

simulating catheter

plexolong 100, pajunk, germany

Device

nonstimulating catheter

Primary outcomes

  1. minimum effective anesthetic volume in 50% of patients

    Time frame: thirty minutes after local anesthetic injection

Secondary outcomes

  1. morphine requirement

    Time frame: intraoperatively

Sponsors and collaborators

Lead sponsor

ASST Gaetano Pini-CTO

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 7, 2013
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.