Superiority of Epidural Placement Technique Using EpiFaith Syringe

NCT ID: NCT04793373

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2026-06-30

Brief Summary

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The aim of this study is to evaluate the impact of EpiFaith® syringe on the establishment of successful epidural labor analgesia, change of elapsed time for identification of epidural space, and learning curve of CA-1 residents.

Detailed Description

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We hypothesize that EpiFaith® syringe, in comparison with conventional glass syringe, will result in a similar overall success rate for catheter placement, but with a larger reduction in change of elapsed time for identification of epidural space and catheter placement of each practitioner. Moreover, we hypothesize that the cumulative learning summary curve using EpiFaith® syringe will be higher than conventional glass syringe in resident trainees, which will show the possible value of EpiFaith® syringe for teaching and learning obstetric epidural anesthesia.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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EpiFaith® group

Study subject will have the epidural placement with an EpiFaith® syringe.

Group Type EXPERIMENTAL

Syringe

Intervention Type DEVICE

A syringe will be used to detect the loss of resistance and needle's entry of epidural space.

Conventional group

Study subject will have the epidural placement with a conventional glass syringe.

Group Type ACTIVE_COMPARATOR

Syringe

Intervention Type DEVICE

A syringe will be used to detect the loss of resistance and needle's entry of epidural space.

Interventions

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Syringe

A syringe will be used to detect the loss of resistance and needle's entry of epidural space.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Females 18 years of age and older at screening
* Request labor epidural analgesia
* Able to give informed consent to participate in the study
* American Society of Anesthesiologists (ASA) class Ⅰ to Ⅲ health status
* BMI ≤ 40 kg/m2

Exclusion Criteria

* BMI \> 40 kg/m2; any contraindication to neuraxial anesthesia (coagulopathy, uncorrected hypovolemia, increased intracranial pressure, or local skin infection)
* Cardiac disease history, marked spinal deformity, previous spinal surgery, or impalpable anatomical landmarks
* Any allergy to bupivacaine or fentanyl
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role lead

Responsible Party

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Jie Zhou

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2020P000677

Identifier Type: -

Identifier Source: org_study_id

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