Stimulating Catheter for Lumbar Plexus

Knee Arthritis Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978275
• Other study ID #: IOGPGC02-13
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2013
• Last updated: February 14, 2014
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: ASST Gaetano Pini-CTO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing total knee arthroplasty

Exclusion Criteria:

• diabetes

• coagulation disorders

• allergy to local anesthetic

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Knee Arthritis Disease

Intervention

Device:
• stimulong 100, pajunk, germany
simulating catheter
• plexolong 100, pajunk, germany
nonstimulating catheter

Locations

Country	Name	City	State
Italy	Istituto Ortopedico G. Pini	Milan	Milano

Sponsors (1)

Lead Sponsor	Collaborator
ASST Gaetano Pini-CTO

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	minimum effective anesthetic volume in 50% of patients		thirty minutes after local anesthetic injection	No
Secondary	morphine requirement		intraoperatively	No