Needle Nerve Contact in Ultrasound Guided Femoral Block

Sponsor
Hospital Clinic of Barcelona (Other)
Overall Status
Unknown status
CT.gov ID
NCT01554722
Collaborator
(none)
44
2
2
4
22
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Needle placement
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Incidence of Intraneural Needle Insertion in Ultrasound Guided Femoral Block: Out of Plane Versus in Plane Approach
Study Start Date :
Nov 1, 2011
Anticipated Primary Completion Date :
Mar 1, 2012
Anticipated Study Completion Date :
Mar 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of intraneural needle insertion in ultrasound-guided femoral block: out-of-plane versus in-plane approach [4 months]

    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

  1. Number of Participants with femoral block success in ultrasound-guided femoral block: out-of-plane versus in-plane approach. [4 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 St Luke'S Roosevelt Hospital, Columbia University New York New York United States 10025
2 University of Barcelona Barcelona Spain

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ana Ruiz, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01554722
Other Study ID Numbers:
  • R6345
First Posted:
Mar 15, 2012
Last Update Posted:
Mar 15, 2012
Last Verified:
Mar 1, 2012
Keywords provided by Ana Ruiz, MD, Hospital Clinic of Barcelona
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2012