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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two handheld ultrasound devices in guiding needle placement for epidurals during labor. One device is traditional, while the other provides automated guidance for users with less than a year of ultrasound experience. The main goal is to determine which method requires fewer needle passes, thus smoothing the procedure. Suitable participants include pregnant individuals without back issues or prior back surgeries who can sit up for the epidural placement. As an unphased trial, this study allows participants to contribute to advancements in medical technology that could enhance labor experiences for many.

Will I have to stop taking my current medications?

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

What prior data suggests that ultrasound-guided epidurals are safe for labor analgesia?

Previous studies have shown that using ultrasound to guide epidurals is safe. Research indicates that ultrasound reduces the number of needle insertions, leading to fewer complications. Specifically, ultrasound guidance cut the number of insertions in half, suggesting a smoother and safer procedure.

For traditional ultrasound, studies have shown improvements in epidural placement. While side effects can occur, serious long-term issues are rare. Both automated and traditional ultrasound methods are generally well-tolerated and have been used safely in various settings.

Overall, evidence suggests that both automated and traditional ultrasound methods for guiding epidurals are safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance how epidurals are administered during labor. Traditional epidurals rely heavily on the skill of the anesthesiologist to accurately place the needle, often using a standard ultrasound to guide them. This trial is testing handheld automated ultrasound devices that could provide real-time, detailed information about the needle's distance to the epidural space and interspace location, potentially reducing the number of needle manipulations required. By improving precision and safety, these new ultrasound methods could make labor epidurals more efficient and comfortable for mothers-to-be.

What evidence suggests that ultrasound-guided epidurals are effective for labor analgesia?

This trial will compare handheld traditional ultrasound with handheld automated ultrasound for guiding epidurals. Studies have shown that ultrasound guidance can reduce needle pokes, leading to less discomfort. Automated ultrasound decreases needle movements by 15% and helps doctors find the right spot faster. Research on traditional ultrasound indicates it improves the accuracy of epidural needle placement, making the process smoother. Both types of ultrasound guidance can enhance pain relief during labor, making it more effective and less stressful. ^{2 3 5 6 7}

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

Low platelet count

Allergies to local anesthetics

I have a blood clotting disorder.

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. bmj.com bmj.com/content/385/bmj-2023-077190

Epidural analgesia during labour and severe maternal ... Epidural analgesia during labour was associated with a 35% reduction in SMM, and showed a more pronounced effect in women with medical indications for epidural ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6555430/

Feasibility of Spinal Anesthesia Placement Using ... Among all patients, use of ultrasound resulted in a 11% greater first-insertion success rate (RR: 1.11 [0.85–1.47], p=0.431), a 15% reduction in needle ...

3. pocusjournal.com pocusjournal.com/article/16298/

A Prospective Cohort Study to Evaluate Needle Passes ... In conclusion, the use of US in our study resulted in a decrease in the procedural time, and number of needle passes and attempts needed to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3417963/

Epidural analgesia for labor: Current techniques - PMC Epidural analgesia is an extremely effective and popular treatment for labor pain. In Canada, the epidural rate varies between the provinces from 30% to 69%.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0007091223005020

Comparative efficacy of ultrasound guidance or ... This NMA provides evidence supporting ultrasound-guided neuraxial puncture compared with use of anatomical landmarks, including indirect comparisons.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11041821/

Safety and Efficacy of Ultrasound-Guided Combined ... Combined thoracic spinal/epidural block results in stable hemodynamics, longer postoperative analgesia with fewer side effects, and greater surgeon and patient ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05052658

Study Details | NCT05052658 | Ultrasound High BMI Study This is a prospective experimental pilot study of full-term non-emergent obese parturients whose labor is being managed with epidural anesthesia to determine if ...