Needle Nerve Contact in Ultrasound Guided Femoral Block

NCT01554722 | Unknown DMC

• 1 other identifier: R6345
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 2

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.

Conditions

Peripheral Nerve Injury

Keywords

Ultrasound guidance; Femoral nerve block; Needle placement; Intraneural needle insertion

Outcome Measures

Primary Outcomes (1)

• 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).

  4 months

Secondary Outcomes (1)

• Number of Participants with femoral block success in ultrasound-guided femoral block: out-of-plane versus in-plane approach.

  4 months

Study Arms (2)

in plane needle placement

EXPERIMENTAL

Procedure: Needle placement

out of plane needle placement

EXPERIMENTAL

Procedure: Needle placement

Interventions

Needle placement PROCEDURE

In plane versus out of plane needle placement techniques

in plane needle placement; out of plane needle placement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (2)

St Luke'S Roosevelt Hospital, Columbia University

New York, New York, 10025, United States

RECRUITING

University of Barcelona

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Xavier Sala-Blanch, MD

  University Clinic Barcelona

  PRINCIPAL INVESTIGATOR

• Ana Ruiz, MD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Admir Hadzic, Prof Dr

  Columbia University St Luke's Hospital

  STUDY DIRECTOR

Central Study Contacts

Ana Ruiz, MD

CONTACT

0034932275558; anaruiz@clinic.ub.es

Xavier Sala-Blanch, MD

CONTACT

0034932275558; Xavier Sala-Blanch <xavi.sala.blanch@gmail.com>

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 15, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

ES (1); US (1)