Epidural; Anesthesia, HeadacheNCT06085027
Comparison of the Epifaith® Syringe With the Plastic Syringe
A study testing Labor analgesia in people with Epidural; Anesthesia, Headache and Analgesia, run by Chang Gung Memorial Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epidural; Anesthesia, Headache, Analgesia
- What is being tested?
- Labor analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA II to III
- Require labor analgesia
- Has submitted inform consent
Who cannot join
- ASA IV or above
- Coagulopathy
- Spinal deformity
- Neurological, psychological, cardiopulmonary disorder
- Active liver or kidney injury
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Compare the Epifaith® Syringe With the Plastic Syringe for Identification of the Epidural Space in Parturients: A Prospective Randomized Control Study
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.
- Conditions
- Epidural; Anesthesia, Headache, Analgesia
- Being tested
- Labor analgesia
- Medical subject headings
- Headache, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor analgesiaProcedure or surgery
Perform epidrual analgesia for parturients between 18 to 45 year-old
| Study group | Role | What they receive |
|---|---|---|
| The Epifaith® syringe | Experimental | Not described Receives: Procedure: Labor analgesia |
| The plastic syringe | Active comparator | Not described Receives: Procedure: Labor analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time consumed to identify the epidural space
Starting on the moment which the syringe be attached to the needle
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural; Anesthesia, HeadacheStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085027
- Sponsor's protocol ID
- 202301331A3
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Epifaith® Syringe With the Plastic Syringe for Identification of the Epidural Space in Parturients: A Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT06085027
- Acronym / sponsor ID
- 202301331A3
- Conditions
- Epidural; Anesthesia, Headache, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Epifaith® syringe | Experimental | Procedure: Labor analgesia |
| The plastic syringe | Active comparator | Procedure: Labor analgesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA II to III
- Require labor analgesia
- Has submitted inform consent
Key exclusion criteria (5 listed)
- ASA IV or above
- Coagulopathy
- Spinal deformity
- Neurological, psychological, cardiopulmonary disorder
- Active liver or kidney injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labor analgesiaPerform epidrual analgesia for parturients between 18 to 45 year-old | Procedure or surgery | The Epifaith® syringe, The plastic syringe |
Primary outcome
Time consumed to identify the epidural space
Time frame: During the procedure
Starting on the moment which the syringe be attached to the needle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Labor analgesia in people with Epidural; Anesthesia, Headache and Analgesia, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng Yang, MD (+886978989351, chubbyming20@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time consumed to identify the epidural space (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.