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Stimulating Catheter for Lumbar Plexus

Primary Purpose

Knee Arthritis Disease

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
stimulong 100, pajunk, germany
plexolong 100, pajunk, germany
Sponsored by
ASST Gaetano Pini-CTO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Arthritis Disease focused on measuring total knee arthroplasty, lumbar plexus block, stimulating catheters, peripheral nerve blocks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing total knee arthroplasty

Exclusion Criteria:

  • diabetes
  • coagulation disorders
  • allergy to local anesthetic

Sites / Locations

  • Istituto Ortopedico G. Pini

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stimulating catheters group

nonstimulating catheters

Arm Description

Lumbar plexus block performed through stimulating catheter

lumbar plexus block through nonstimulating catheters

Outcomes

Primary Outcome Measures

minimum effective anesthetic volume in 50% of patients

Secondary Outcome Measures

morphine requirement

Full Information

First Posted
October 25, 2013
Last Updated
February 14, 2014
Sponsor
ASST Gaetano Pini-CTO
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1. Study Identification

Unique Protocol Identification Number
NCT01978275
Brief Title
Stimulating Catheter for Lumbar Plexus
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ASST Gaetano Pini-CTO

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis Disease
Keywords
total knee arthroplasty, lumbar plexus block, stimulating catheters, peripheral nerve blocks

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stimulating catheters group
Arm Type
Experimental
Arm Description
Lumbar plexus block performed through stimulating catheter
Arm Title
nonstimulating catheters
Arm Type
Active Comparator
Arm Description
lumbar plexus block through nonstimulating catheters
Intervention Type
Device
Intervention Name(s)
stimulong 100, pajunk, germany
Intervention Description
simulating catheter
Intervention Type
Device
Intervention Name(s)
plexolong 100, pajunk, germany
Intervention Description
nonstimulating catheter
Primary Outcome Measure Information:
Title
minimum effective anesthetic volume in 50% of patients
Time Frame
thirty minutes after local anesthetic injection
Secondary Outcome Measure Information:
Title
morphine requirement
Time Frame
intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing total knee arthroplasty Exclusion Criteria: diabetes coagulation disorders allergy to local anesthetic
Facility Information:
Facility Name
Istituto Ortopedico G. Pini
City
Milan
State/Province
Milano
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

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Stimulating Catheter for Lumbar Plexus

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