Ultrasound High BMI Study

Obesity Complicating Childbirth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052658
• Other study ID #: 69690
• Status: Completed
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: December 13, 2022

Study information

• Verified date: January 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity Complicating Childbirth

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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