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OpenTrials
Completed

NCT Number: NCT05052658

Ultrasound High BMI Study

This is a prospective experimental pilot study of full-term non-emergent obese parturients whose labor is being managed with epidural anesthesia to determine if neuraxial block placement with pre-procedure handheld ultrasound affects time to placement or number of needle passes. Approximately 25 patients, presenting for delivery at the University of Kentucky HealthCare Obstetrics Department, will be randomized to either the ultrasound or palpation group, between study approval and 31 July 2022.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

About this study

Placement of neuraxial blocks is commonly achieved by palpating surface landmarks. This somewhat "blind" technique to identify the spinal space becomes more difficult and less reliable in obese patients. Ultrasound devices have become common and successful with blocks and venous access, both involving mostly soft tissues. Application of conventional ultrasound for neuraxial blocks has been limited by its bulkiness, limited imaging for bony structures and a long learning curve. A newly developed pocket-size ultrasound addresses these limitations by providing real-time pattern recognition for spinal bony structures and 3D overlay for recognition of midline spinous process and intervertebral space using an automated artificial intelligent algorithm. The hypothesis is that ultrasound guidance will reduce time to epidural placement and reduce number of passes in obese patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject requesting and consenting for a labor epidural, aged 18-50 and BMI between 35-59.9 at admission for labor.
  • Subject with American Society of Anesthesiologists score equal to or less than III.
  • Subject with singleton gestation equal to or greater than 37 weeks.
  • Subjects with planned labor epidural in sitting position.

Exclusion criteria

  • Patients with urgent or emergent diagnoses involving the health of the patient or child, such as abnormal fetal heart tracing.
  • Patients with major back abnormalities (back surgery, significant scoliosis).
  • Patients with contra-indication to neuraxial block (bleeding risk, local anesthetic allergy).
  • Patients having cesarean section or combined spinal epidural.
  • Patients whose epidurals are performed by residents in first month of obstetric rotation and/or having performed fewer than 20 labor epidurals in total.
  • Patient needing a translator for procedure.
  • Patients who are prisoners.

Treatment and study plan

Neuraxial block placement

Procedure

The time and ease of administering neuraxial blocks in high BMI patients,for the management of labor and delivery pain, will be assessed.

Primary outcomes

  1. Time to placement of neuraxial block in parturients with BMI=35-59.9

    Time frame: Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour

    Time period from initially touching the patient's skin to removal of Tuohy needle after catheter placement.

  2. Number of passes to placement of neuraxial block in parturients with BMI=35-59.9

    Time frame: Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour

    Number of times the epidural needle is removed from skin and re-entered

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Registry information

Official study title

Time for Neuraxial Block Placement With Use of Ultrasound in Patients With High BMI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2021
Registry last updated
Jan 25, 2023

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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