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OpenTrials
Completed

NCT Number: NCT03596333

Color Doppler Ultrasound to Locate Needle in Labor Epidural

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Augusta University

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Retrospective Chart Review

Other

We conducted a retrospective chart review to evaluate the stored ultrasound images used during labor epidural placement, as well as demographic and anesthetic variables.

Primary outcomes

  1. Epidural needle tip position

    Time frame: 5 minutes (from insertion of epidural needle until identification of position)

    Identification of posterior complex (dura and ligamentum flavum with color flow Doppler

Secondary outcomes

  1. Epidural catheter position

    Time frame: 5 minutes (from advancement of epidural catheter until identification of position)

    Identification of epidural catheter with color flow Doppler

  2. Epidural failure rate

    Time frame: 12 hours (labor duration)

    Number of failed epidurals requiring replacement

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2018
Registry last updated
Jul 23, 2018

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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