Trial record 5 of 8 for:    Open Studies | "Peripheral Nerve Injuries"

Needle Nerve Contact in Ultrasound Guided Femoral Block

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Hospital Clinic of Barcelona.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention
Peripheral Nerve Injury
Procedure: Needle placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Incidence of Intraneural Needle Insertion in Ultrasound Guided Femoral Block: Out of Plane Versus in Plane Approach

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 44
Study Start Date: November 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554722

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

Locations
United States, New York
St Luke'S Roosevelt Hospital, Columbia University Recruiting
New York, New York, United States, 10025
Principal Investigator: Admir Hadzic, PROF.DR         
Spain
University of Barcelona Recruiting
Barcelona, Spain
Contact: Xavier Sala-Blanch, MD    0034932275558    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         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Ana Ruiz, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01554722     History of Changes
Other Study ID Numbers: R6345
Study First Received: February 27, 2012
Last Updated: March 13, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Clinic of Barcelona:
Ultrasound guidance
Femoral nerve block
Needle placement
Intraneural needle insertion

Additional relevant MeSH terms:
Peripheral Nerve Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014