Needle Nerve Contact in Ultrasound Guided Femoral Block

This study is currently recruiting participants.

Verified March 2012 by Hospital Clinic of Barcelona

Sponsor:

Information provided by (Responsible Party):

Ana Ruiz, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT01554722

First received: February 27, 2012

Last updated: March 13, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2012

Last Updated Date

March 13, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of intraneural needle insertion in ultrasound-guided femoral block: out-of-plane versus in-plane approach [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01554722 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Participants with femoral block success in ultrasound-guided femoral block: out-of-plane versus in-plane approach. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Needle Nerve Contact in Ultrasound Guided Femoral Block

Official Title ^ICMJE

Incidence of Intraneural Needle Insertion in Ultrasound Guided Femoral Block: Out of Plane Versus in Plane Approach

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).

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Peripheral Nerve Injury

Intervention ^ICMJE

Procedure: Needle placement

In plane versus out of plane needle placement techniques

Study Arm (s)

Experimental: in plane needle placement
Intervention: Procedure: Needle placement
Experimental: out of plane needle placement
Intervention: Procedure: Needle placement

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Ana Ruiz, MD	0034932275558	anaruiz@clinic.ub.es
Contact: Xavier Sala-Blanch, MD	0034932275558	Xavier Sala-Blanch <xavi.sala.blanch@gmail.com>

Location Countries ^ICMJE

United States, Spain

Administrative Information

NCT Number ^ICMJE

NCT01554722

Other Study ID Numbers ^ICMJE

R6345

Has Data Monitoring Committee

Yes

Responsible Party

Ana Ruiz, Hospital Clinic of Barcelona

Study Sponsor ^ICMJE

Hospital Clinic of Barcelona

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Xavier Sala-Blanch, MD	University Clinic Barcelona
Principal Investigator:	Ana Ruiz, MD	University of Barcelona
Study Chair:	Julia Martinez-Ocon, MD	University of Barcelona
Study Chair:	Maria J Carretero, MD	University of Barcelona
Study Chair:	Gerard Sánchez-Etayo, MD	University of Barcelona
Study Director:	Admir Hadzic, Prof Dr	Columbia University St Luke's Hospital

Information Provided By

Hospital Clinic of Barcelona

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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