LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40

MetroHealth Medical Center

Status: Invitation-only

Conditions: Labor Pain; Obesity, Morbid

Treatments: Diagnostic Test: Lumbar Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06305260

STUDY00000324

Details and patient eligibility

About

The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI >40) obstetric patient population. The main questions it aims to answer are:

• Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?
• Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older
• English Speaking
• BMI (Body Mass Index) > 40
• Ability to provide informed consent and verbally disclose their medical history

Exclusion criteria

• History of spine surgery, scoliosis, or other spinal abnormality which could complicate epidural placement
• Patients with platelet counts <70,000 or patients who are on anticoagulation, or patients who are on anticoagulation, both would exclude any patient from receiving an epidural.
• Minors
• Adults unable to make their own decisions or with cognitive issues or developmental delays
• Prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Traditional Lumbar Palpation

No Intervention group

Description:

This group will include parturients who are randomized to traditional lumbar palpation prior to epidural placement. This is the current standard of care.

Pre-procedural Lumbar Ultrasound

Experimental group

Description:

This group will include parturients who are randomized to a pre-procedural lumbar ultrasound prior to epidural placement.

Treatment:

Diagnostic Test: Lumbar Ultrasound