Ultrasound vs Palpation for Epidurals in Labor Pain

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: ASA III or IV, Severe pain, Previous spinal surgery, BMI > 37, Height < 60 inches, Scoliosis, others

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether ultrasound, a medical imaging technique, can simplify and enhance the safety of placing epidural catheters for labor pain management. The study compares the traditional palpation method with ultrasound-guided placement, focusing on whether ultrasound can reduce associated risks. Healthy women planning to receive an epidural during labor may qualify for this trial. As an unphased trial, it allows participants to contribute to research that could improve epidural procedures for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ultrasound-guided epidural catheter placement is safe for labor pain management?

Research has shown that using ultrasound to assist in placing an epidural can enhance the procedure's accuracy. One study found that ultrasound facilitated easier and more precise insertion of the epidural needle and tube, reducing the likelihood of complications. Another study found that ultrasound could lower the epidural failure rate from 5% to just 1%. This reduction is significant because a failed epidural can lead to increased pain during labor. Although epidurals carry some risks, such as incorrect placement causing pain or discomfort, ultrasound appears to mitigate these issues. Overall, ultrasound guidance is generally well-tolerated and may provide a safer method for placing epidurals during labor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing ultrasound-guided and palpation-guided techniques for epidural placement in labor pain management. Most epidurals are placed using palpation, where the doctor feels for anatomical landmarks. However, ultrasound guidance offers a more precise way to locate the right spot for the epidural needle. This technique could lead to fewer complications, quicker placements, and improved comfort for the patient. Finding out which method is more effective and safer could significantly impact how we manage labor pain.

What evidence suggests that this trial's techniques could be effective for epidural placement?

This trial will compare ultrasound-guided epidural catheter placement with palpation-guided placement for managing labor pain. Studies have shown that ultrasound assistance can increase the success of epidural catheter placement. Research indicates that ultrasound imaging improves anesthesia quality compared to traditional methods. Ultrasound use also enhances safety, with higher success rates and more effective pain relief. In contrast, some studies have found traditional methods that rely on feeling for landmarks to be less effective. Overall, ultrasound guidance shows promise for improving outcomes in epidural procedures. ^{1 2 6 7 8}

Who Is on the Research Team?

Philip E Hess, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This clinical trial is for healthy pregnant women in labor (ASA I or II) who are planning to receive an epidural for pain relief and have consented to the procedure. It's not suitable for those with certain health conditions that would exclude them from participation.

Inclusion Criteria

I am a healthy pregnant woman scheduled for an epidural or spinal block.

Exclusion Criteria

I have a serious but not life-threatening health condition.

Unable to participate in the study due to severe pain

I cannot have spinal or epidural pain relief.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Phase

Randomized comparison of ultrasound versus palpation for epidural catheter insertion in laboring women

Duration not specified

1 visit (in-person)

Second Phase

Single cohort trial to assess ultrasound imaging for reliable placement below the L3 vertebra

Duration not specified

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Palpation-guided Epidural Catheter Placement
• Ultrasound-guided Epidural Catheter Placement

Trial Overview

The study is comparing two methods of placing an epidural catheter: the traditional palpation technique versus using ultrasound guidance. The goal is to see if ultrasound can improve needle placement and reduce risks associated with epidural procedures.

How Is the Trial Designed?

Group I: ultrasound guidance Active Control 1 Intervention

placement of spinal or combined spinal epidural using ultrasound to guide entry position

Group II: palpation guidance Placebo Group 1 Intervention

placement of spinal or combined spinal epidural needle using palpation to guide entry position

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8316939/

Preprocedure ultrasound imaging combined with palpation ...

Our study showed a significant improvement of the epidural puncture and catheterization procedures when using preprocedure ultrasound imaging ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11480820/

The Power of Color Flow Doppler Ultrasonography Versus ...

The study reported a successful and predominantly safe outcome, with high success rates in flow visualization and effective anesthesia coverage.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0952818001003786

Efficacy of ultrasound imaging in obstetric epidural ...

Conclusion: The clinical use of ultrasound for epidural catheter placement may improve regional anesthesia. The use of ultrasound resulted in superior quality ...

4.

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 ...

5.

ajog.org

ajog.org/article/S0002-9378(22)00463-X/fulltext

implications for labor outcomes and maternal-fetal health

Some forms of epidural analgesia were associated with higher risk of assisted vaginal delivery, but the use of newer modalities has been shown ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S000293782200463X

Modern labor epidural analgesia: implications for ...

Some forms of epidural analgesia were associated with higher risk of assisted vaginal delivery, but the use of newer modalities has been shown to abolish this ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00811304?tab=table

Real-time Ultrasound Guided Labor Epidural Placement

Hypothesis: Ultrasound guided labor epidural placement in real-time will decrease the traditional epidural failure rate from 5% to 1%. All pregnant women in ...

8.

aquila.usm.edu

aquila.usm.edu/cgi/viewcontent.cgi?article=1164&context=dnp_capstone

Utilizing Ultrasound-Guided Technology for Epidural ...

However, the incorrect placement of an epidural catheter can result in inadequate control of labor pain and other adverse complications to both mother and fetus ...