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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

Must not have

Patients with known spinal deformities

Contraindication for epidural analgesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within first 90 minutes following catheter placement

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I plan to use epidural pain relief for my vaginal delivery.

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My overall health is good to moderately impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a known spinal deformity.

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I cannot have epidural pain relief due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within first 90 minutes following catheter placement

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of needle insertion attempts and redirections

Successful epidural catheter placement

Secondary study objectives

Complications

Needle depth

Pressure pain thresholds and pain scores

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met