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
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
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
NCT ID
NCT01978275
First Posted
October 25, 2013
Last Updated
February 14, 2014
Sponsor
ASST Gaetano Pini-CTO
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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