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

Not Applicable

• Conditions: Obesity, Morbid; Labor Pain
• Interventions: Diagnostic Test: Lumbar Ultrasound

• 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

Arm && Interventions

Group	Intervention	Description
Pre-procedural Lumbar Ultrasound	Lumbar Ultrasound	This group will include parturients who are randomized to a pre-procedural lumbar ultrasound prior to epidural placement.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total time to epidural space	Day of Epidural	Total time to epidural space observed via loss of resistance.
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

Trial Locations

Locations (1)

MetroHealth Hospital; 🇺🇸 Cleveland, Ohio, United States