Comparison of the Epifaith® Syringe With the Plastic Syringe

NCT ID: NCT06085027

Last Updated: 2023-10-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2024-10-31

Brief Summary

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The goal of this clinical trial is to compare the efficiency of identifying epidural space with either the Epifaith® syringe or the plastic syringe in parturients. The main questions it aims to answer are:

* Whether it consume less time identifying epidural space with the Epifaith® syringe
* Whether the usage of the Epifaith® syringe decrease the complication rate and failure of labor analgesia Participants will receive labor analgesia either with the Epifaith® syringe or the plastic syringe conducted by experienced resident doctors.

Detailed Description

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Conditions

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Epidural; Anesthesia, Headache Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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The Epifaith® syringe

Group Type EXPERIMENTAL

Labor analgesia

Intervention Type PROCEDURE

Perform epidrual analgesia for parturients between 18 to 45 year-old

The plastic syringe

Group Type ACTIVE_COMPARATOR

Labor analgesia

Intervention Type PROCEDURE

Perform epidrual analgesia for parturients between 18 to 45 year-old

Interventions

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Labor analgesia

Perform epidrual analgesia for parturients between 18 to 45 year-old

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA II to III
* Require labor analgesia
* Has submitted inform consent

Exclusion Criteria

* ASA IV or above
* Coagulopathy
* Spinal deformity
* Neurological, psychological, cardiopulmonary disorder
* Active liver or kidney injury
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sheng Yang, MD

Role: CONTACT

+886978989351

Rou-Yan Lin, MD

Role: CONTACT

+886978989198

Other Identifiers

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202301331A3

Identifier Type: -

Identifier Source: org_study_id

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