Ultrasound Device for Labor Pain and C-sections

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Anticoagulants

Disqualifiers: Bleeding disorders, Neurological dysfunction, Spinal surgery, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultrasound device to help doctors place needles more accurately for spinal and epidural anesthesia during procedures like C-sections. The device aims to improve safety and effectiveness by using real-time imaging for better needle placement. Suitable participants include those needing spinal or epidural anesthesia during surgery, with healthy skin at the needle site and no history of spinal surgery or major spinal issues. As an unphased trial, participants can help advance medical technology that may enhance safety and effectiveness in anesthesia procedures.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using anti-coagulants (blood thinners), you may not be eligible to participate.

What prior data suggests that this ultrasound placement device is safe for labor pain and C-sections?

Research has shown that ultrasound devices can guide needle placement during epidurals and spinal procedures, enhancing safety. One study found that devices like the Accuro reduce the number of needle adjustments needed. This results in fewer attempts to position the needle correctly, making the procedure safer and more comfortable for patients.

Another study suggested that handheld ultrasounds could aid in pain relief during labor, known as CSE analgesia. This indicates that ultrasound devices can enhance the effectiveness and safety of these procedures.

Although the specific Accuro 3S device tested in this study is experimental, the FDA has approved the basic technology for other uses. This approval suggests the technology is generally considered safe. However, as the current research seeks to improve accuracy and efficiency, all results remain under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ultrasound placement device for labor pain and C-sections because it offers a novel way to assist with intrathecal neuraxial anesthesia. Unlike traditional methods, which rely on manual techniques for anesthesia administration, this device uses ultrasound technology to help guide the block placement more accurately. This could potentially improve precision, reduce complications, and enhance pain management for patients during labor and surgical procedures like C-sections.

What evidence suggests that this ultrasound placement device is effective for labor pain and C-sections?

Research has shown that using ultrasound to guide epidural anesthesia during labor reduces the number of needle attempts needed. One study found that ultrasound guidance lowered the average number of attempts from about two to just over one. Another study demonstrated that ultrasound made it quicker to place the needle for spinal anesthesia. In this trial, participants undergoing surgery will receive neuraxial intrathecal anesthesia, with block placement assisted by the investigational ultrasound device. Ultrasound guidance also helps doctors make better decisions during labor by providing clear images. These findings suggest that ultrasound can improve pain management and increase the success rate of epidural procedures during labor. ^{4 6 7 8 9}

Who Is on the Research Team?

Clemens Ortner, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals experiencing labor pain or preparing for a C-section who require neuraxial anesthesia. The study seeks participants to test an ultrasound device designed to improve the accuracy of needle placement during epidural and spinal procedures.

Inclusion Criteria

I am eligible and have agreed to undergo spinal or epidural anesthesia.

My skin is healthy where the epidural or spinal anesthesia will be placed.

Exclusion Criteria

Skin dyscrasias or allergies to the ultrasound procedure

Body Mass Index (BMI) less than 20 kg/m2

Known allergies to ultrasound gel

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive neuraxial anesthesia with the investigational device Accuro 3S, including ultrasound-guided needle placement and image recording

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the neuraxial procedure, including incidence of post-dural puncture headache and failed block

7 days

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound Placement Device

Trial Overview The Accuro 3S, an experimental ultrasound device, is being tested for its ability to guide clinicians in real-time during needle insertion for neuraxial anesthesia. It aims to enhance safety by providing precise anatomical guidance and improving needle visualization.

How Is the Trial Designed?

Group I: Intrathecal neuraxial procedure Experimental Treatment 1 Intervention

Participants undergoing surgery, receiving neuraxial intrathecal anesthesia with block placement in part by the investigational device.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Rivanna Medical, Inc.

Collaborator

Trials

1

Recruited

100+

Citations

1. nature.com nature.com/articles/s41598-023-50407-7

Handheld ultrasound-assisted versus palpation-guided ... Similarly, our results showed decrease in time from the first LOR until CSF efflux in the ultrasound group.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7090204/

Ultrasound-Guided Transversus Abdominis Plane Block for ... Ultrasound-guided TAPB is an effective analgesic method that provides good analgesia during lower abdominal surgery.

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

Efficacy of ultrasound imaging in obstetric epidural ... Using ultrasound for structure detection, the rate of puncture attempts were significantly (p < 0.013) reduced from 2.18 ± 1.07 to 1.35 ± 0.61. The mean rate of ...

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07170-6

The role of intrapartum ultrasound combined with free position ... Combining intrapartum ultrasound with free maternal positions shows promise in improving delivery outcomes for women with abnormal fetal positions during labor.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11560775/

The value of ultrasonographic factors in predicting ... Ultrasound measurements provide objective data, thus improving obstetricians' ability to make informed clinical judgments during labor induction ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405844022036064

Efficacy and safety of intrauterine device placement during ... IUD placement during CS is effective in preventing unintended pregnancies within the first year after delivery, with operative outcomes unaffected.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10835986/

Ultrasound-guided caudal anaesthesia combined with ... A comparison of spinal and epidural anesthesia for cesarean section following epidural labor analgesia: a retrospective cohort study.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04592926

Pre-Insertion Ultrasound for Lateral-Position Spinal in ... The purpose of this study is to evaluate the impact of lumbar ultrasound anatomic mapping using the Accuro device on the number of needle redirections.

9. ait-journal.com ait-journal.com/doi/10.5114/ait.2024.138542

Safety and complications of labour epidural analgesia in ... Barriers included a lack of knowledge, equipment, and privileges. The survey data showed that CRNAs who utilised ultrasound for epidural/spinal needle placement ...