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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the EpiZact Device treatment for epidural analgesia?

The research shows that epidural analgesia using bupivacaine and opioids can effectively manage pain, as seen in patients with chronic pain and cancer. The effectiveness of such treatments often depends on the correct placement and distribution of the medication in the epidural space, which suggests that devices like EpiZact could potentially improve outcomes by ensuring proper delivery. ^{1 2 3 4 5}

How does the EpiZact Device treatment for epidural analgesia differ from other treatments?

The EpiZact Device is unique because it likely automates the process of locating the epidural space, potentially improving accuracy and reducing reliance on the anesthesiologist's tactile sensation. This could lead to more consistent and safer epidural analgesia compared to traditional methods that depend heavily on the clinician's experience and manual techniques. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of the study is to learn more about a new device, the EpiZact Epidural Device, that may be helpful for reducing the likelihood of wet tap when a labor epidural is placed. When epidurals are placed correctly the needle stops just in front of the space in the body that contains cerebrospinal fluid. When the epidural is advanced a short distance further, leakage of cerebrospinal fluid can occur. This is known as a wet tap. A wet tap can result in a severe headache and at times other complications. The goal of this clinical trial is to learn if the use of the EpiZact device prevents wet taps in pregnant women receiving epidurals for relief of labor pain. The main questions this study aims to answer are: 1. What the rate of wet tap with the EpiZact device? 2. What is the rate of failed epidural placement with the EpiZact device? All patients in the study will receive an epidural with the EpiZact device. The investigators will compare the results with patients not in the study that receive an epidural without the EpiZact device.

Research Team

Brandon M Togioka, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Routine postoperative epidural analgesia. X-ray control of epidural catheter position and prevention of the spread of epidural contrast media]. [2013]

2. Canada pubmed.ncbi.nlm.nih.gov

The epidural opioid internalized system. [2007]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Prevention of epidural catheter migration: a comparative evaluation of two tunneling techniques. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Insufficient analgesia following epidural application of morphine in obstetrics (author's transl)]. [2013]

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

Patient-controlled epidural analgesia or continuous infusion: advantages and disadvantages of different modes of delivering epidural analgesia for labour. [2019]

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

Portable optical epidural needle-a CMOS-based system solution and its circuit design. [2021]

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

The learning curve associated with the epidural technique using the Episure™ AutoDetect™ versus conventional glass syringe: an open-label, randomized, controlled, crossover trial of experienced anesthesiologists in obstetric patients. [2012]

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

Evaluation of an automatic approach device to the epidural space of Beagle dogs. [2023]

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

Clinical results with the acoustic puncture assist device, a new acoustic device to identify the epidural space. [2021]

10. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Eyes on the needle: Identification and confirmation of the epidural space. [2022]