Back to resultsComparison of Two Techniques for Placement of Perineural Femoral Catheters. (HLOCSTIM2)
Primary Purpose
Postoperative Pain, Anterior Cruciate Ligament Reconstruction
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Placement of a femoral catheter with the hydrolocalization technique
Placement of a femoral neurostimulating catheter
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- adults
- BMI less than 30
Exclusion Criteria:
- known allergies to local anesthetics or other drugs used
- patient refusal
- any local or systemic contraindication to the use of popliteal block
Sites / Locations
- Attikon HospitalRecruiting
- Policlinico Tor VergataRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
HLOC
NS
Arm Description
Placement of a femoral catheter with the hydrolocalization technique
Placement of a femoral neurostimulating catheter
Outcomes
Primary Outcome Measures
local anesthetic consumption
Secondary Outcome Measures
Pain scores with a VAS scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01726192
Brief Title
Comparison of Two Techniques for Placement of Perineural Femoral Catheters.
Acronym
HLOCSTIM2
Official Title
Comparison of Ultrasound Hydrolocalization Technique Versus Neurostimulation for Placement of Continuous Femoral Catheters.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of femoral perineural catheters in comparison with stimulating catheters. A non inferiority trial.
Detailed Description
The investigators will randomize patients that will undergo anterior cruciate ligament reconstruction.
Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group HLOC) or a neurostimulating catheter (group NS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anterior Cruciate Ligament Reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLOC
Arm Type
Active Comparator
Arm Description
Placement of a femoral catheter with the hydrolocalization technique
Arm Title
NS
Arm Type
Active Comparator
Arm Description
Placement of a femoral neurostimulating catheter
Intervention Type
Procedure
Intervention Name(s)
Placement of a femoral catheter with the hydrolocalization technique
Other Intervention Name(s)
Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
Intervention Description
Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
Intervention Type
Procedure
Intervention Name(s)
Placement of a femoral neurostimulating catheter
Primary Outcome Measure Information:
Title
local anesthetic consumption
Time Frame
36 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain scores with a VAS scale
Time Frame
36 hours postoperatively
Other Pre-specified Outcome Measures:
Title
incidence of side effects, consumption of iv analgesics
Time Frame
36 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults
BMI less than 30
Exclusion Criteria:
known allergies to local anesthetics or other drugs used
patient refusal
any local or systemic contraindication to the use of popliteal block
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana F Sidiropoulou, MD, PhD
Phone
00302105832371
Email
tatianasid@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana F Sidiropoulou, MD, PhD
Organizational Affiliation
Attikon Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Theodosios Saranteas, MD, PhD
Organizational Affiliation
Attikon Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mario Dauri, MD
Organizational Affiliation
Policlinico Tor Vergata
Official's Role
Principal Investigator
Facility Information:
Facility Name
Attikon Hospital
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana F Sidiropoulou, MD, PhD
First Name & Middle Initial & Last Name & Degree
Theodosios Saranteas, MD, PhD
Facility Name
Policlinico Tor Vergata
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Dauri, MD
Email
mario.dauri@ptvonline.it
First Name & Middle Initial & Last Name & Degree
Mario Dauri, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22088876
Citation
Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. No abstract available.
Results Reference
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Comparison of Two Techniques for Placement of Perineural Femoral Catheters.
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