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OpenTrials
Completed

NCT Number: NCT02451813

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Luke's-Roosevelt Hospital Center

New York, 10025, United States

About this study

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:

  • Needle tip slightly indenting the fascia iliaca lateral to the femoral nerve
  • Needle tip advanced through fascia iliaca
  • Needle tip slightly indenting the anterior surface of the femoral nerve
  • Needle tip withdrawn 1 mm from nerve.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 1 minute

Secondary outcomes

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

    Time frame: 1 minute

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

    Time frame: 1 minute

  3. Incidence of paresthesias

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 22, 2015
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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