Stimulating Catheter for Lumbar Plexus

Phase 4

Completed

• Conditions: Knee Arthritis Disease

• Registration Number: NCT01978275
• Lead Sponsor: ASST Gaetano Pini-CTO

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-07
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2014-02-14
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• patients undergoing total knee arthroplasty

Exclusion Criteria

• diabetes
• coagulation disorders
• allergy to local anesthetic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
minimum effective anesthetic volume in 50% of patients	thirty minutes after local anesthetic injection

Secondary Outcome Measures

Name	Time	Method
morphine requirement	intraoperatively

Trial Locations

Locations (1)

Istituto Ortopedico G. Pini; 🇮🇹 Milan, Milano, Italy