Needle Nerve Contact in Ultrasound Guided Femoral Block

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

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Nerve Injury
• Intervention / Treatment: Procedure: Needle placement

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: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • University of Barcelona
    • Contact: Xavier Sala-Blanch, MD; Phone Number: 0034932275558; Email: Xavier Sala-Blanch <xavi.sala.blanch@gmail.com>
    • Sub-Investigator: Ana Ruiz, MD
    • Principal Investigator: Xavier Sala-Blanch, MD
    • Sub-Investigator: Julia Martinez-Ocón, MD
    • Sub-Investigator: Maria J Carretero, MD
    • Sub-Investigator: Gerard Sánchez-Etayo, MD
• United States
  • New York
    • New York, New York, United States, 10025
      • Recruiting
      • St Luke'S Roosevelt Hospital, Columbia University
      • Principal Investigator: Admir Hadzic, PROF.DR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: in plane needle placement	Procedure: Needle placement; In plane versus out of plane needle placement techniques
Experimental: out of plane needle placement	Procedure: Needle placement; In plane versus out of plane needle placement techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4 months

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: March 13, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): March 15, 2012
• Last Update Submitted That Met QC Criteria: March 13, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Ultrasound guidance; Femoral nerve block; Needle placement; Intraneural needle insertion
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries
• Other Study ID Numbers: R6345