The Relationship Between Needle Position and Injection Pressure During Femoral Nerve Block

Orthopedic Disorders Clinical Trial

Official title:

The Relationship Between Needle Position and Injection Pressure During Femoral Nerve Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451813
• Other study ID #: StLukeNY
• Status: Completed
• Phase: N/A
• First received: March 3, 2015
• Last updated: April 13, 2016
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

Recent evidence suggests that injection pressure monitoring may be able to predict needle nerve contact in the brachial plexus nerve block model, but little is known about multifascicular nerves. The investigators hypothesize that injection pressure monitoring can reliably predict needle-nerve contact during femoral nerve block.

Description:

Single center, observational study. Patients scheduled for elective lower limb surgery with femoral nerve block will be recruited. Femoral nerve will be identified using a linear ultrasound transducer. A 22 GA 5 cm nerve block needle will be inserted with bevel downward and advanced to the following conditions:

1. Needle tip slightly indenting the fascia iliaca lateral to the femoral nerve

2. Needle tip advanced through fascia iliaca

3. Needle tip slightly indenting the anterior surface of the femoral nerve

4. Needle tip withdrawn 1 mm from nerve.

At each of these conditions, 1 ml of dextrose solution will be injected via an automated pump at 10 ml/min and the spread of injectate observed sonographically. Simultaneously, a blinded observer will measure opening injection pressure using both an electronic and a mechanical transducer. If opening pressure reaches 15 psi, this investigator will halt the injection. In addition, minimum threshold current required to elicit a motor response will be recorded for conditions 3 and 4. Patients will be contacted at 7 days and asked about any adverse effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65

• ASA physical status I-III

• scheduled for lower limb surgery where femoral block is part of intended analgesic plan

Exclusion Criteria:

• Contraindication to femoral nerve block (e.g. infection)

• BMI > 35 kg/m2

• inability to communicate postoperative symptoms

• pre-existing neurologic deficits in the operative extremity

• allergy to local anesthetics

• history of opioid dependence

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Orthopedic Disorders

Intervention

Procedure:
• Apposition of needle bevel against femoral nerve
Indentation of femoral nerve and fascia iliaca by block needle and measurement of opening injection pressure during the controlled injection of 1 ml of dextrose (D5W) solution

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of high opening injection pressure (15 psi or greater) when needle tip in contact with nerve		1 minute	No
Secondary	Incidence of high opening injection pressure (15 psi or greater) at other needle locations		1 minute	No
Secondary	Minimum threshold current to elicit a motor response with needle-nerve contact and needle disengagement		1 minute	No
Secondary	Incidence of paresthesias		1 week	No