Clinical trial NCT01554722: Needle Nerve Contact in Ultrasound Guided Femoral Block
Official title: Incidence of Intraneural Needle Insertion in Ultrasound Guided Femoral Block: Out of Plane Versus in Plane Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Nerve Injury
Keywords: Ultrasound guidance
Femoral nerve block
Needle placement
Intraneural needle insertion
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Number of intraneural needle insertion in ultrasound-guided femoral block: out-of-plane versus in-plane approach
timeFrame: 4 months
Secondary outcomes:
measure: Number of Participants with femoral block success in ultrasound-guided femoral block: out-of-plane versus in-plane approach.
timeFrame: 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: St Luke'S Roosevelt Hospital, Columbia University
state: New York
city: Barcelona
country: Spain
facility: University of Barcelona
Study officials:
affiliation: University Clinic Barcelona
name: Xavier Sala-Blanch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Ana Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Julia Martinez-Ocon, MD
role: STUDY_CHAIR
affiliation: University of Barcelona
name: Maria J Carretero, MD
role: STUDY_CHAIR
affiliation: University of Barcelona
name: Gerard Sánchez-Etayo, MD
role: STUDY_CHAIR
affiliation: Columbia University St Luke's Hospital
name: Admir Hadzic, Prof Dr
role: STUDY_DIRECTOR
References: