NCT05052658

Ultrasound High BMI Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Kentucky · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Obesity Complicating Childbirth

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-27
• Primary completion: 2022-12-13
• Completion: 2022-12-13
• First posted: 2021-09-22
• Last updated: 2023-01-25

Locations

1 site across 1 country: United States