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Pre-procedural Lumbar Ultrasound for Obesity (LOTUS Trial)

N/A
Waitlist Available
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of epidural
Awards & highlights

LOTUS Trial Summary

This trial aims to see if using a pre-procedural lumbar ultrasound is better than the traditional method of palpation for placing epidurals in obese pregnant patients. They want to know if using

Who is the study for?
This trial is for pregnant individuals with a BMI over 40 who are experiencing labor pain and need an epidural. It's not specified who can't join, but typically those with conditions affecting the spine or certain infections might be excluded.Check my eligibility
What is being tested?
The LOTUS Trial is testing if using lumbar ultrasound before placing an epidural in obese patients is better than the usual method of feeling by hand (palpation). Participants will be randomly assigned to one of these two methods.See study design
What are the potential side effects?
Lumbar ultrasound itself has no significant side effects, but general risks associated with epidurals include soreness where the needle goes in, headache, or difficulty urinating.

LOTUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of epidural
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of epidural for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Epidural Redirects
Secondary outcome measures
Epidural replacement rate
Number of attempts at a different level
Patient satisfaction
+1 more

LOTUS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pre-procedural Lumbar UltrasoundExperimental Treatment1 Intervention
This group will include parturients who are randomized to a pre-procedural lumbar ultrasound prior to epidural placement.
Group II: Traditional Lumbar PalpationActive Control1 Intervention
This group will include parturients who are randomized to traditional lumbar palpation prior to epidural placement. This is the current standard of care.

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor
114 Previous Clinical Trials
21,239 Total Patients Enrolled
5 Trials studying Obesity
1,025 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being accepted for enrollment in this research study?

"Data from clinicaltrials.gov shows that this particular medical trial is not actively seeking participants. Initially listed on November 1, 2023, the last update was made on March 8, 2024. Despite its closure to new candidates, there are currently 144 alternative studies open for patient enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40
2023. "LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06305260.
All > Morbid Obesity
~81 spots leftby Dec 2024
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