Comparison of the Epifaith® Syringe With the Plastic Syringe

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06085027

Collaborator

(none)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Epidural; Anesthesia, Headache Analgesia	Procedure: Labor analgesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Compare the Epifaith® Syringe With the Plastic Syringe for Identification of the Epidural Space in Parturients: A Prospective Randomized Control Study

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The Epifaith® syringe	Procedure: Labor analgesia Perform epidrual analgesia for parturients between 18 to 45 year-old
Active Comparator: The plastic syringe	Procedure: Labor analgesia Perform epidrual analgesia for parturients between 18 to 45 year-old

Arm

Intervention/Treatment

Experimental: The Epifaith® syringe

Procedure: Labor analgesia

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

Active Comparator: The plastic syringe

Procedure: Labor analgesia

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

Outcome Measures

Primary Outcome Measures

Time consumed to identify the epidural space [During the procedure]
Starting on the moment which the syringe be attached to the needle

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT06085027

Other Study ID Numbers:

202301331A3

First Posted:

Oct 16, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Headache

Study Results

No Results Posted as of Oct 16, 2023