Ultrasound High BMI Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-27

Study Completion Date

2022-12-13

Brief Summary

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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.

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Detailed Description

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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

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Obesity Complicating Childbirth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Palpation Group

Group Type ACTIVE_COMPARATOR

Neuraxial block placement

Intervention Type PROCEDURE

The time and ease of administering neuraxial blocks in high BMI patients,for the management of labor and delivery pain, will be assessed.

Ultrasound Group

Group Type EXPERIMENTAL

Neuraxial block placement

Intervention Type PROCEDURE

The time and ease of administering neuraxial blocks in high BMI patients,for the management of labor and delivery pain, will be assessed.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No