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

NCT02451813 | Completed DMC

• 1 other identifier: StLukeNY
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthopedic Disorders

Keywords

opening injection pressure; femoral nerve block; fascia iliaca; ultrasound guided nerve block

Outcome Measures

Primary Outcomes (1)

• Incidence of high opening injection pressure (15 psi or greater) when needle tip in contact with nerve

  1 minute

Secondary Outcomes (3)

• Incidence of high opening injection pressure (15 psi or greater) at other needle locations

  1 minute

• Minimum threshold current to elicit a motor response with needle-nerve contact and needle disengagement

  1 minute

• Incidence of paresthesias

  1 week

Study Arms (1)

Intervention

EXPERIMENTAL

A 22 GA 5 cm nerve block needle will be advanced to the following conditions: 1. Needle tip slightly indenting the fascia iliaca 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 Needle tip withdrawn 1 mm from nerve.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 and spread of injectate observed sonographically. A blinded observer will measure injection pressure. 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.

Procedure: Apposition of needle bevel against femoral nerve

Interventions

Apposition of needle bevel against femoral nerve PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• ASA physical status I-III
• scheduled for lower limb surgery where femoral block is part of intended analgesic plan

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Malikah Latmore, MD

  Mount Sinai St. Luke's Mount Sinai Roosevelt Hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: May 22, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 15, 2016

Record last verified: 2015-03

Locations

US (1)