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

Obesity, Morbid Clinical Trial

— LOTUS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06305260
• Other study ID #: STUDY00000324
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Obesity, Morbid

Intervention

Diagnostic Test:
• Lumbar Ultrasound
Investigators will utilize our ultrasound machine to complete a pre-procedural lumbar ultrasound prior to epidural placement.

Locations

Country	Name	City	State
United States	MetroHealth Hospital	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidural Redirects	Total number of epidural needle redirections	Day of Epidural
Secondary	Total time to epidural space	Total time to epidural space observed via loss of resistance.	Day of Epidural
Secondary	Number of attempts at a different level	Number of attempts at a different lumbar level.	Day of Epidural
Secondary	Epidural replacement rate	Includes epidurals that needed to be replaced because of failed epidural or inadequate pain relief	Day of Epidural
Secondary	Patient satisfaction	Patient's satisfaction with epidural experience observed by a survey in post-partum	24 hours post-epidural