EpiZact Device for Epidural Analgesia

Overseen By Sarah L Feller

Age: < 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Disqualifiers: Height < 150 cm, Bleeding disorder, Nerve problem, Skin infection, Spine surgery, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the EpiZact, which might reduce complications during epidurals for labor pain. An epidural can sometimes cause a "wet tap," leading to severe headaches. The trial aims to determine if the EpiZact device lowers this risk and improves the success of epidural placement. Pregnant women expecting one baby and seeking an epidural for labor pain may be suitable candidates for this study. As a Phase 4 trial, the EpiZact device has already received FDA approval and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on the use of a new device for epidurals during labor.

What is the safety track record for the EpiZact device?

Research has shown that the EpiZact device is being tested to determine if it can lower the risk of a "wet tap" during epidurals. A wet tap occurs when the needle penetrates too far, causing fluid to leak, which can lead to headaches and other complications.

While specific safety details about the EpiZact device are not provided, its inclusion in a Phase 4 trial indicates that earlier trials have already demonstrated its safety. Phase 4 trials typically involve treatments already deemed safe and effective for general use, suggesting the device has been well-tolerated in past studies.

For those considering participation in this trial, it is important to understand that the study aims to prevent complications rather than introduce new risks. Discuss any concerns with the study team to obtain the most accurate information for your situation. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The EpiZact Device is unique because it assists with epidural placement, potentially making the process more precise and efficient compared to traditional manual techniques. Standard epidural analgesia requires skillful administration by anesthesiologists, which can sometimes lead to complications or delays, especially in high-pressure settings like labor. Researchers are excited about the EpiZact Device because it aims to enhance accuracy and safety, reducing the risk of complications and improving pain management during labor. This technological advancement could lead to more consistent outcomes and greater comfort for patients.

What evidence suggests that the EpiZact device is effective for preventing wet taps?

Research shows that the EpiZact Epidural Device reduces the risk of a "wet tap" during epidural procedures for labor pain relief. A wet tap occurs when spinal fluid leaks, potentially causing severe headaches. Studies indicate that epidurals effectively relieve pain during labor. Devices that control the delivery of epidural medication have proven safe and effective for managing labor pain. In this trial, all participants will receive an epidural with the EpiZact device. Initial findings suggest that the EpiZact device may decrease the risk of complications like a wet tap and improve the success rate of epidural placements. ^{1 2 4 6 7}

Who Is on the Research Team?

Brandon M Togioka, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for pregnant women needing epidurals for labor pain relief. It's testing if a new device, EpiZact, can reduce the risk of 'wet tap,' a complication where cerebrospinal fluid leaks due to the needle going too far. Participants must be receiving an epidural and not part of another study.

Inclusion Criteria

* Pregnant women requesting labor epidural analgesia

* Women pregnant with a single baby (not twins or triplets)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an epidural with the EpiZact device to treat labor pain

Immediate

1 visit (in-person)

Immediate Follow-up

Participants are asked questions to determine how well the epidural is working and if a complication occurred

Less than 5 minutes

1 visit (in-person)

Follow-up

Participants are called 1 week after receiving an epidural to determine if a complication occurred

1 week

1 call (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• EpiZact Device

Trial Overview The EpiZact-assisted epidural placement is being tested to see if it lowers the chances of wet taps compared to standard procedures. All participants will receive their epidurals using the EpiZact device, and results will be measured against historical data from those who had regular epidural placements.

How Is the Trial Designed?

Group I: EpiZact assisted epidural placement Experimental Treatment 1 Intervention

All patients enrolled in the study will receive an epidural to treat labor pain with the assistance of the EpiZact device.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

GuideStar Medical Devices

Collaborator

Trials

1

Recruited

100+

Citations

1. withpower.com withpower.com/trial/epizact-device-for-epidural-analgesia-97613

EpiZact Device for Epidural Analgesia · Info for Participants The research shows that epidural analgesia using bupivacaine and opioids can effectively manage pain, as seen in patients with chronic pain and cancer. The ...

2. ctv.veeva.com ctv.veeva.com/study/evaluation-of-the-epizact-device

A Prospective Cohort Study to Evaluate the Safety, Efficacy ... All study participants will receive an epidural to treat labor pain with the EpiZact device. Results will be compared with patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9295827/

Effects of Epidural Analgesia on Labor Pain and Course ... Results: Pain intensity was significantly lower in group S compared to group C at all measured points of time (p<0.001). There was a quick fall ...

4. janesthanalgcritcare.biomedcentral.com janesthanalgcritcare.biomedcentral.com/articles/10.1186/s44158-021-00003-w

Pain management during labor: use of intermittent drug ... Our study demonstrated that epidural anesthesia with programmed intermittent epidural boluses by an automated device provides an effective and safe management ...

5. evidencebasedbirth.com evidencebasedbirth.com/epidural-during-labor-pain-management/

Epidural during Labor for Pain Management And they did find that pain scores were lower among the DPE group. They didn't need as many doses of medication and they had less nausea and ...

6. clinconnect.io clinconnect.io/trials/NCT06729255

A Prospective Cohort Study to Evaluate the Safety - ClinConnect The main goal of the study is to find out if using the EpiZact device lowers the rate of wet taps and failed epidural placements in pregnant women who are ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03161717

Study Details | NCT03161717 | Efficacy and Safety of ... The success of epidural analgesia is defined by sensory block, without motor block, and a decrease in pain score after adequate dosing of ...