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Comparison of the Epifaith® Syringe With the Plastic Syringe

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06085027
Enrollment
300
Registered
2023-10-16
Start date
2023-10-31
Completion date
2024-10-31
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Epidural; Anesthesia, Headache

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.

Interventions

PROCEDURELabor analgesia

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

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Time consumed to identify the epidural spaceDuring the procedureStarting on the moment which the syringe be attached to the needle

Contacts

Primary ContactSheng Yang, MD
chubbyming20@cgmh.org.tw+886978989351
Backup ContactRou-Yan Lin, MD
emily920703@cgmh.org.tw+886978989198

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026