Needle Nerve Contact in Ultrasound Guided Femoral Block

NCT ID: NCT01554722

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-03-31

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).

Conditions

Peripheral Nerve Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

in plane needle placement

Group Type: EXPERIMENTAL

Needle placement

Intervention Type: PROCEDURE

In plane versus out of plane needle placement techniques

out of plane needle placement

Group Type: EXPERIMENTAL

Needle placement

Intervention Type: PROCEDURE

In plane versus out of plane needle placement techniques

Interventions

Needle placement

In plane versus out of plane needle placement techniques

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Ana Ruiz

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xavier Sala-Blanch, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinic Barcelona

Ana Ruiz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Julia Martinez-Ocon, MD

Role: STUDY_CHAIR

University of Barcelona

Maria J Carretero, MD

Role: STUDY_CHAIR

University of Barcelona

Gerard Sánchez-Etayo, MD

Role: STUDY_CHAIR

University of Barcelona

Admir Hadzic, Prof Dr

Role: STUDY_DIRECTOR

Columbia University St Luke's Hospital

Locations

St Luke'S Roosevelt Hospital, Columbia University

New York, New York, United States

Site Status: RECRUITING

University of Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Countries

United States; Spain

Central Contacts

Ana Ruiz, MD

Role: CONTACT

anaruiz@clinic.ub.es

0034932275558

Xavier Sala-Blanch, MD

Role: CONTACT

Xavier Sala-Blanch <xavi.sala.blanch@gmail.com>

0034932275558

Facility Contacts

Xavier Sala-Blanch, MD

Role: primary

Xavier Sala-Blanch <xavi.sala.blanch@gmail.com>

0034932275558

Other Identifiers

R6345

Identifier Type: -

Identifier Source: org_study_id