EpiZact Device for Epidural Analgesia

Recruiting in Palo Alto (17 mi)

Brandon Togioka - Associate Professor ...

Overseen byBrandon M Togioka, MD

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Oregon Health and Science University

No Placebo Group

Prior Safety Data

Trial Summary

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)

Treatment Details

Interventions

EpiZact Device (Device)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: EpiZact assisted epidural placementExperimental Treatment1 Intervention

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