Ultrasound High BMI Study

NCT05052658 | Completed

• 1 other identifier: 69690
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity Complicating Childbirth

Keywords

High BMI, pregnancy, ultrasound

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Palpation Group

ACTIVE COMPARATOR

Procedure: Neuraxial block placement

Ultrasound Group

EXPERIMENTAL

Procedure: Neuraxial block placement

Interventions

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.

Palpation Group; Ultrasound Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Study Officials

• Regina Fragneto, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dept of Anesthesiology

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: October 27, 2021
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)