Needle Nerve Contact in Ultrasound Guided Femoral Block

Peripheral Nerve Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01554722
• Other study ID #: R6345
• Status: Recruiting
• Phase: N/A
• First received: February 27, 2012
• Last updated: March 13, 2012
• Start date: November 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Hospital Clinic of Barcelona
• Contact: Ana Ruiz, MD
• Phone: 0034932275558
• Email: anaruiz[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Peripheral Nerve Injury

Intervention

Procedure:
• Needle placement
In plane versus out of plane needle placement techniques

Locations

Country	Name	City	State
Spain	University of Barcelona	Barcelona
United States	St Luke'S Roosevelt Hospital, Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes