Color Doppler Ultrasound to Locate Needle in Labor Epidural

Use of Color Doppler Ultrasonography to Confirm the Position of a Labor Epidural Needle - a Retrospective Case Series

Color Flow Doppler (CFD) utilizes Doppler information obtained from signals sent to and received from a transducer. This information is color-encoded and then displayed as color on an overlay of the two-dimensional image. The color scale represents both speed and direction of flow within a discrete area of the image. CFD has been recently used to determine the position of the epidural catheter. However its role in labor epidural has yet to be defined. This study describes the use of CFD to confirm the position of the tip of the epidural needle in the context of labor analgesia. This study hypothesized that CFD is a feasible method for identifying proper epidural needle placement prior to epidural catheter advancement.

Study Overview

• Status: Completed
• Conditions: Labor Pain; Obstetric Pain
• Intervention / Treatment: Other: Retrospective chart review

Detailed Description

After obtaining approval by the Institutional Review Board and a waiver of informed consent, thirty-five pregnant patients who underwent an ultrasound guided labor epidural between August of 2017 and June of 2018, were included in this retrospective review. The ultrasound guided labor epidural was used in those in which an anticipated technical difficulty with landmark epidural space localization was expected. These included those patients with diagnosis of obesity and lumbar scoliosis, as well as those with poorly defined surface lumbar bone anatomy. Patients with history of spine surgery were excluded. Patient data were obtained from the institutional electronic medical records. Demographic data, intervertebral level of insertion, dermatome level, and failure rate of epidural needle placement using color flow Doppler were noted for each patient.

Labor analgesia was obtained via a combined spinal epidural technique. Sterile preparation and draping of the area was followed by placement of a curvilinear ultrasound transducer in a sterile sheath. The ultrasound was used to identify the interspinous space. The epidural needle was guided with the use of real time ultrasound by the use of an out of plane technique. A two hand technique was used to manipulate the needle and the ultrasound probe. A 17G Tuohy needle (B. Braun Medical Inc, Bethlhem, PA, USA) was advanced until loss of resistance to normal saline was attained. Confirmation of the epidural space with the use of color flow Doppler (CFD) was then obtained after injection of up to 10 mL of normal saline through the epidural needle. A 27G pencil-point spinal needle (B. Braun Medical Inc, Bethlhem, PA, USA) was then introduced through the epidural needle until cerebro-spinal fluid (CSF) was obtained. Use of intrathecal fentanyl or local anesthetic plus fentanyl was then used as a bolus in the spinal space. A 21G epidural catheter (B. Braun Medical Inc, Bethlhem, PA, USA) was then threaded into the epidural space.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Term pregnant patients who underwent labor epidural assisted with ultrasound

Description

Inclusion Criteria:

• Pregnant patients who had labor epidural placed for clinical indications, in whom ultrasound was used to assist the procedure.

Exclusion Criteria:

• Poor quality ultrasound images judged by experienced anesthesiologist
• Patients with history of lumbar spine surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidural needle tip position	Identification of posterior complex (dura and ligamentum flavum with color flow Doppler	5 minutes (from insertion of epidural needle until identification of position)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidural catheter position	Identification of epidural catheter with color flow Doppler	5 minutes (from advancement of epidural catheter until identification of position)
Epidural failure rate	Number of failed epidurals requiring replacement	12 hours (labor duration)

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Principal Investigator: Efrain Riveros Perez, MD, Medical College of Georgia. Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 1230080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No