NCT06305260
Enrolling By Invitation
Not Applicable
The LOTUS Trial: Lumbar Ultrasound Utility in Obstetric Patients With BMI > 40
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Morbid
- Sponsor
- MetroHealth Medical Center
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Epidural Redirects
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
- •Adults unable to make their own decisions or with cognitive issues or developmental delays
- •Prisoners
Outcomes
Primary Outcomes
Epidural Redirects
Time Frame: Day of Epidural
Total number of epidural needle redirections
Secondary Outcomes
- Total time to epidural space(Day of Epidural)
- Number of attempts at a different level(Day of Epidural)
- Epidural replacement rate(Day of Epidural)
- Patient satisfaction(24 hours post-epidural)
Study Sites (1)
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