Clinical trial NCT06729255: A Prospective Cohort Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device
Official title: A Single Academic Center, Prospective Cohort With Retrospective Loss-of-resistance Comparator, Proof of Concept Study to Evaluate the Safety, Efficacy, and Usability of the EpiZact Device for Parturients Undergoing Epidural Labor Analgesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postdural Puncture Headache
Epidural Analgesia, Obstetric
Keywords: EpiZact
Wet Tap
unintentional dural puncture
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: GuideStar Medical Devices
First posted: 2024-12-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will perform a prospective cohort with retrospective loss-of-resistance comparator, proof of concept study involving patients undergoing epidural labor analgesia at OHSU University Hospital.

This is an open-label (unblinded) study.

The study will involve one arm:

1) A prospectively enrolled convenience sample of patients that receive epidural labor analgesia with the assistance of the EpiZact device.

Results will be matched with a sample of patients identified through retrospective chart review that have received standard of care epidural labor analgesia with the loss-of-resistance technique.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The purpose of the study is to learn if use of the EpiZact device decreases the number of wet taps that occur when epidurals are placed. The EpiZact device has a technology that automatically stops the epidural needle when it enters the epidural space. In theory, this should decrease the likelihood of a wet tap. The standard epidural to treat labor pain does not have this capability. The study device may cause fewer wet taps than the standard epidural. All study participants will receive an epidural to treat labor pain with the EpiZact device. Results will be compared with patients receiving epidurals around the same time without the EpiZact device.

If a participant's screening questions show that they can take part in the study, and the participant chooses to be a part of the study, medical records from OHSU or other facilities may be reviewed. Information reviewed may include treatment history, medications, surgeries, allergies, scans, and lab results. The participant will then receive an epidural with the EpiZact device. After the epidural is placed, the participant will be asked a few questions to determine how well the epidural is working and if a complication occurred. The questions are expected to take less than 5 minutes to answer. Participants will also be called 1 week after receiving an epidural to determine if a complication occurred. This call is expected to last less than 5 minutes.

Eligibility criteria: Inclusion Criteria:

* Pregnant women requesting labor epidural analgesia
* Women pregnant with a single baby (not twins or triplets)

Exclusion Criteria:

* Women requesting not to have a labor epidural
* Height less than 150 cm
* A bleeding disorder, nerve problem, or skin infection that contraindicates receiving an epidural
* A women receiving a combined spinal epidural (CSE) or a dural puncture epidural (DPE)
* A history of spine surgery
* Allergy to local anesthetics (numbing medicine) or skin cleaning solutions
* Decisionally impaired individuals

Primary outcomes:
measure: Proportion of Participants with an Unintentional Dural Puncture
timeFrame: 1 week
Secondary outcomes:
measure: Proportion of Participants with Failed Labor Epidural Placement
timeFrame: 2 hours
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Brandon M Togioka, MD
role: PRINCIPAL_INVESTIGATOR
References: