An interventional study of Neuraxial block placement in Obesity Complicating Childbirth, sponsored by University of Kentucky. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by University of Kentucky · Not applicable, Interventional, and Supportive care
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.
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.
University of Kentucky is the lead sponsor of 68 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Neuraxial block placement
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.
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 frame: 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 frame: Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University of Kentucky