Ultrasound-Guided Epidurals for Labor Analgesia

Overseen By Antonio Gonzalez, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Coagulopathy, Low platelets, Anesthetic allergies

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Up to 60 minutes per procedure

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (\< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is ultrasound-guided epidural insertion safe for humans?

Research suggests that using ultrasound guidance for epidural insertion can help reduce complications like bone contact, which may improve safety. Studies in both animal models and a small human study indicate that this method can safely guide the needle to the correct position. ^{1 2 3 4 5}

How is the treatment 'Ultrasound-Guided Epidurals for Labor Analgesia' different from other treatments for labor pain?

This treatment is unique because it uses ultrasound technology to guide the placement of the epidural needle, which can improve accuracy and reduce the risk of complications compared to traditional methods that rely on the practitioner's experience and feel. By using ultrasound, the procedure can be more precise, potentially leading to fewer failed attempts and better pain relief during labor. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Ultrasound-Guided Epidurals for Labor Analgesia?

Research shows that using ultrasound guidance for epidurals can improve the accuracy of needle placement, reducing failure rates and potentially improving pain relief during labor. An augmented reality ultrasound system demonstrated a higher success rate compared to traditional ultrasound guidance, suggesting that advanced imaging techniques can enhance the effectiveness of epidural procedures. ^{4 6 8 9 10}

Who Is on the Research Team?

Antonio Gonzalez, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals classified as ASA-1, ASA-2, or ASA-3 who need labor epidural analgesia. They should have no back deformities, be able to sit upright for the procedure, and not have had lumbar surgery before. Also, they mustn't be allergic to ultrasound gel.

Inclusion Criteria

ASA-1, ASA-2, and ASA-3

I can sit upright for an epidural.

I have never had surgery on my lower back.

Exclusion Criteria

I have a blood clotting disorder.

Low platelet count

Allergies to local anesthetics

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo ultrasound-guided labor epidural procedures using either a traditional handheld ultrasound or an automated device

Up to 60 minutes per procedure

1 visit (in-person)

Follow-up

Participants are monitored for patient satisfaction and accuracy of the ultrasound devices

15-20 minutes after epidural placement

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Automated Ultrasound
• Labor Epidurals
• Needle Manipulation
• Traditional Ultrasound
• Ultrasound Guidance

Trial Overview The study compares needle guidance in labor epidurals between a traditional handheld ultrasound device and an automated one when used by sonographers with less than a year of experience. The main focus is on how many times the needle has to pass.

How Is the Trial Designed?

Group I: Handheld Automated ultrasound Experimental Treatment 1 Intervention

Automated device provides automatic information pertaining to distance to epidural space distance and interspace location.

Group II: Handheld traditional ultrasound Active Control 1 Intervention

Traditional US will be used to compare number of needle manipulations to the handheld US.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Ultrasound using the transverse approach to the lumbar spine provides reliable landmarks for labor epidurals. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Color your epidural: color flow Doppler to confirm labor epidural needle position. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Development and Evaluation of an Augmented Reality Ultrasound Guidance System for Spinal Anesthesia: Preliminary Results. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-facilitated epidurals and spinals in obstetrics. [2016]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Application of ultrasound-guided epidural catheter indwelling in painless labour. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Eyes in the needle: novel epidural needle with embedded high-frequency ultrasound transducer--epidural access in porcine model. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Ultrasound imaging of the lumbar spine in the transverse plane: the correlation between estimated and actual depth to the epidural space in obese parturients. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Novel 3D ultrasound system for midline single-operator epidurals: a feasibility study on a porcine model. [2018]

9. England pubmed.ncbi.nlm.nih.gov

A prototype axial ultrasound needle guide to reduce epidural bone contact. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Ultrasound decreases the failed labor epidural rate in resident trainees. [2022]