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

NCT06305260 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-03-20

No results posted yet for this study

Summary

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.

Conditions

  • Obesity, Morbid
  • Labor Pain

Interventions

DIAGNOSTIC_TEST

Lumbar Ultrasound

Investigators will utilize our ultrasound machine to complete a pre-procedural lumbar ultrasound prior to epidural placement.

Sponsors & Collaborators

  • MetroHealth Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06305260 on ClinicalTrials.gov