Skip to content

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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06305260
Acronym
LOTUS
Enrollment
150
Registered
2024-03-12
Start date
2023-11-01
Completion date
2024-12-30
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain, Obesity, Morbid

Keywords

Labor Epidural

Brief 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.

Interventions

DIAGNOSTIC_TESTLumbar Ultrasound

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

Sponsors

MetroHealth Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Epidural RedirectsDay of EpiduralTotal number of epidural needle redirections

Secondary

MeasureTime frameDescription
Total time to epidural spaceDay of EpiduralTotal time to epidural space observed via loss of resistance.
Number of attempts at a different levelDay of EpiduralNumber of attempts at a different lumbar level.
Epidural replacement rateDay of EpiduralIncludes epidurals that needed to be replaced because of failed epidural or inadequate pain relief
Patient satisfaction24 hours post-epiduralPatient's satisfaction with epidural experience observed by a survey in post-partum

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026