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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

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

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

NCT ID

NCT01554722

First Posted

February 27, 2012

Last Updated

March 13, 2012

Sponsor

Hospital Clinic of Barcelona

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

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

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

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

anaruiz@clinic.ub.es

First Name & Middle Initial & Last Name or Official Title & Degree

Xavier Sala-Blanch, MD

Phone

0034932275558

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

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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