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Needle Nerve Contact in Ultrasound Guided Femoral Block

Primary Purpose

Peripheral Nerve Injury

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Needle placement
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Nerve Injury focused on measuring Ultrasound guidance, Femoral nerve block, Needle placement, Intraneural needle insertion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA physical status 1-3 patients
  • Diagnosis of trochanteric or cervical hip fracture
  • Hip replacement under spinal anesthesia

Exclusion Criteria:

  • Patients under the age of 65 years or over the age of 90 years

Sites / Locations

  • St Luke'S Roosevelt Hospital, Columbia UniversityRecruiting
  • University of BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

in plane needle placement

out of plane needle placement

Arm Description

Outcomes

Primary Outcome Measures

Number of intraneural needle insertion in ultrasound-guided femoral block: out-of-plane versus in-plane approach
The incidence of needle-nerve contact is higher with the out-of-plane approach (inserting the needle into the fascia at the midpoint over the femoral nerve)needle-nerve contact than with the in-plane approach (inserting the needle lateral to the femoral nerve).

Secondary Outcome Measures

Number of Participants with femoral block success in ultrasound-guided femoral block: out-of-plane versus in-plane approach.
The efficacy of the out-of-plane approach (inserting the needle into the fascia at the midpoint over the femoral nerve)needle-nerve contact and the in-plane approach (inserting the needle lateral to the femoral nerve).

Full Information

First Posted
February 27, 2012
Last Updated
March 13, 2012
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT01554722
Brief Title
Needle Nerve Contact in Ultrasound Guided Femoral Block
Official Title
Incidence of Intraneural Needle Insertion in Ultrasound Guided Femoral Block: Out of Plane Versus in Plane Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ultrasound-guided femoral nerve block is a common regional anesthesia technique. The optimal method of needle guidance (in-plane versus out-of-plane) with regards to the block efficacy and avoidance of needle-nerve contact has not been established. In this study the investigators tests the hypothesis that the incidence of needle-nerve contact is higher with the needle insertion in an out-of-plane than with the in-plane approach.
Detailed Description
Fourty-four patients with hip fracture (American Society of Anesthesiologists physical status 1-3) are being randomized to receive the femoral block with an out-of-plane (needle inserted at a 45°-60° angle 1 cm caudal to the midpoint of the ultrasound probe just above the femoral nerve) or an in-plane technique (needle inserted 0.5 cm from the side of the probe lateral to the femoral nerve). The data collected includes the depth of needle insertion at the endpoint before injection, response to nerve stimulation, distribution of the injected volume in relation to the nerve (anterior vs posterior, the latter indicating impalement), block efficacy at 20 minutes and 24 hours, and any signs of nerve injury).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injury
Keywords
Ultrasound guidance, Femoral nerve block, Needle placement, Intraneural needle insertion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
in plane needle placement
Arm Type
Experimental
Arm Title
out of plane needle placement
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Needle placement
Intervention Description
In plane versus out of plane needle placement techniques
Primary Outcome Measure Information:
Title
Number of intraneural needle insertion in ultrasound-guided femoral block: out-of-plane versus in-plane approach
Description
The incidence of needle-nerve contact is higher with the out-of-plane approach (inserting the needle into the fascia at the midpoint over the femoral nerve)needle-nerve contact than with the in-plane approach (inserting the needle lateral to the femoral nerve).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Number of Participants with femoral block success in ultrasound-guided femoral block: out-of-plane versus in-plane approach.
Description
The efficacy of the out-of-plane approach (inserting the needle into the fascia at the midpoint over the femoral nerve)needle-nerve contact and the in-plane approach (inserting the needle lateral to the femoral nerve).
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA physical status 1-3 patients Diagnosis of trochanteric or cervical hip fracture Hip replacement under spinal anesthesia Exclusion Criteria: Patients under the age of 65 years or over the age of 90 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Ruiz, MD
Phone
0034932275558
Email
anaruiz@clinic.ub.es
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Sala-Blanch, MD
Phone
0034932275558
Email
Xavier Sala-Blanch <xavi.sala.blanch@gmail.com>
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Sala-Blanch, MD
Organizational Affiliation
University Clinic Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Ruiz, MD
Organizational Affiliation
University of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julia Martinez-Ocon, MD
Organizational Affiliation
University of Barcelona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria J Carretero, MD
Organizational Affiliation
University of Barcelona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gerard Sánchez-Etayo, MD
Organizational Affiliation
University of Barcelona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Admir Hadzic, Prof Dr
Organizational Affiliation
Columbia University St Luke's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St Luke'S Roosevelt Hospital, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Admir Hadzic, PROF.DR
Facility Name
University of Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Sala-Blanch, MD
Phone
0034932275558
Email
Xavier Sala-Blanch <xavi.sala.blanch@gmail.com>
First Name & Middle Initial & Last Name & Degree
Ana Ruiz, MD
First Name & Middle Initial & Last Name & Degree
Xavier Sala-Blanch, MD
First Name & Middle Initial & Last Name & Degree
Julia Martinez-Ocón, MD
First Name & Middle Initial & Last Name & Degree
Maria J Carretero, MD
First Name & Middle Initial & Last Name & Degree
Gerard Sánchez-Etayo, MD

12. IPD Sharing Statement

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Needle Nerve Contact in Ultrasound Guided Femoral Block

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