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

Not Applicable

• Conditions: Obesity, Morbid; Labor Pain

• Registration Number: NCT06305260
• Lead Sponsor: MetroHealth Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-12-11
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-12
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Epidural Redirects	Day of Epidural	Total number of epidural needle redirections

Secondary Outcome Measures

Name	Time	Method
Number of attempts at a different level	Day of Epidural	Number of attempts at a different lumbar level.
Epidural replacement rate	Day of Epidural	Includes epidurals that needed to be replaced because of failed epidural or inadequate pain relief
Patient satisfaction	24 hours post-epidural	Patient's satisfaction with epidural experience observed by a survey in post-partum
Total time to epidural space	Day of Epidural	Total time to epidural space observed via loss of resistance.

Trial Locations

Locations (1)

MetroHealth Hospital; 🇺🇸 Cleveland, Ohio, United States