← Back to Search

Ultrasound-guided Epidural Analgesia

3D Ultrasound-Guided Epidural for Labor Pain in Obese Pregnant Women

N/A
Waitlist Available
Led By Rovnat Babazade, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requesting epidural analgesia for anticipated vaginal delivery
American Society of Anesthesiologists physical status class I, II, or III
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within first 90 minutes following catheter placement
Awards & highlights

Study Summary

This trial will compare two methods of giving epidural pain relief during childbirth.

Who is the study for?
This trial is for pregnant individuals with a BMI of 40 or higher who are at term and want an epidural for pain relief during vaginal delivery. They should be in good to moderate health (ASA class I-III). Those with spinal deformities, allergies to ultrasound gel or local anesthetics, contraindications for epidurals, or unable to understand the consent cannot participate.Check my eligibility
What is being tested?
The study compares two methods of guiding epidural analgesia: the traditional 'Blind Approach' versus using the Rivanna Accuro 3D Ultrasound Device. Participants will be randomly assigned to one of these two groups to see which method has higher success rates.See study design
What are the potential side effects?
While not specific side effects are listed for this trial, typical risks associated with epidurals may include soreness where the needle is inserted, headache, or drop in blood pressure. The use of ultrasound might minimize some risks by improving accuracy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I plan to use epidural pain relief for my vaginal delivery.
Select...
My overall health is good to moderately impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within first 90 minutes following catheter placement
This trial's timeline: 3 weeks for screening, Varies for treatment, and within first 90 minutes following catheter placement for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of needle insertion attempts and redirections
Successful epidural catheter placement
Secondary outcome measures
Complications
Needle depth
Pressure pain thresholds and pain scores
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Rivanna Accuro 3D Ultrasound DeviceExperimental Treatment1 Intervention
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Group II: PalpationActive Control1 Intervention
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
56,562 Total Patients Enrolled
10 Trials studying Obesity
320 Patients Enrolled for Obesity
Rovnat Babazade, MDPrincipal InvestigatorThe University of Texas Medical Branch

Media Library

Rivanna Accuro 3D Ultrasound Device (Ultrasound-guided Epidural Analgesia) Clinical Trial Eligibility Overview. Trial Name: NCT03405311 — N/A
Obesity Research Study Groups: Palpation, Rivanna Accuro 3D Ultrasound Device
Obesity Clinical Trial 2023: Rivanna Accuro 3D Ultrasound Device Highlights & Side Effects. Trial Name: NCT03405311 — N/A
Rivanna Accuro 3D Ultrasound Device (Ultrasound-guided Epidural Analgesia) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03405311 — N/A

Frequently Asked Questions

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

Are participants under the age of fifty eligible for this clinical experiment?

"The eligible patient cohort for this clinical trial spans between 18 to 50 years of age."

Answered by AI

What is the current enrollment figure of this trial?

"Affirmative. Information from clinicaltrials.gov makes it clear that this study is currently recruiting, with the original post date of February 20th 2018 and most recent update on January 3rd 2022. The investigation desires to enlist 308 volunteers across a single location."

Answered by AI

Is enrollment in this experiment currently open?

"The clinicaltrials.gov registry indicates that this medical study is presently seeking participants; it was first posted on February 20th 2018 and the most recent revisions were made January 3rd 2022."

Answered by AI

Is there room for me in this research endeavor?

"The trial is currently seeking 308 individuals, aged 18 to 50 years old, who are suffering from pain and have BMI values of 40 or higher. Furthermore, pregnant patients can also be considered for the study."

Answered by AI

What are the main objectives of this research endeavor?

"The primary goal of this clinical trial, to be measured over a 90 minute period following catheter placement, is the count of insertion attempts and redirections. Subsequently, procedural difficulty will be rated using a 10-point Likert scale, complications related to the epidural will be noted down, as well as needle depth from skin and measured depth via ultrasound."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient
2018. "3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03405311.
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top