Ultrasound High BMI Study

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity Complicating Childbirth
• Intervention / Treatment: Procedure: Neuraxial block placement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Palpation Group	Procedure: Neuraxial block placement; The time and ease of administering neuraxial blocks in high BMI patients,for the management of labor and delivery pain, will be assessed.
Experimental: Ultrasound Group	Procedure: Neuraxial block placement; The time and ease of administering neuraxial blocks in high BMI patients,for the management of labor and delivery pain, will be assessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to placement of neuraxial block in parturients with BMI=35-59.9	Time period from initially touching the patient's skin to removal of Tuohy needle after catheter placement.	Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour
Number of passes to placement of neuraxial block in parturients with BMI=35-59.9	Number of times the epidural needle is removed from skin and re-entered	Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour

Collaborators and Investigators

• Sponsor: University of Kentucky
• Investigators: Principal Investigator: Regina Fragneto, MD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: High BMI, pregnancy, ultrasound
• Other Study ID Numbers: 69690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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