Epidural AnalgesiaNCT07395622
EpiFaith Resident Learning Curve Trial
A study testing EpiFaith epidural syringe in people with Epidural Analgesia and Epidural Analgesia for Labour and Delivery, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study aims to evaluate the impact of the EpiFaith® syringe on the learning curve of anesthesia residents for the labor epidural technique. Anesthesia residents with prior experience placing \< 5 labor epidurals will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epidural Analgesia, Epidural Analgesia for Labour and Delivery, Learning Curve
- What is being tested?
- EpiFaith epidural syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anesthesiology residents with fewer than 5 prior epidural placement experiences
Who cannot join
- anesthesiology residents with more than 5 prior epidural placement experiences
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Michaela K Farber, MD MS, 617-759-1609, mfarber@bwh.harvard.edu
About this study
Official title: Impact of the EpiFaith® Syringe on the Learning Curve of Anesthesia Residents for the Labor Epidural Technique: A Quasi-Experimental Study
This study aims to evaluate the impact of the EpiFaith® syringe on the learning curve of anesthesia residents for the labor epidural technique. Anesthesia residents with prior experience placing \< 5 labor epidurals will be enrolled. Their performance of 20 sequential labor epidural placements with either standard technique with a beveled glass syringe or the EpiFaith® syringe will be observed. Successful epidural placement over time with sequential epidural placement attempts will be measured between groups. The primary outcome will be rate of successful epidural placement. Success will be defined as a composite of 4 criteria: maximum 3 attempts for placement; no need to re-site at a different level; no required intervention by the supervising attending anesthesiologist; and adequate analgesia with a visual analog score (VAS) \<3 at 30 minutes. We hypothesize that use of the EpiFaith® syringe will enable a faster learning curve for successful epidural placement. A cumulative sum chart (CUSUM) analysis will evaluate whether the EpiFaith® syringe causes deviation from the control learning curve. Secondary outcomes will include rate of inadvertent dural puncture and epidural replacement rate.
Read the detailed description
The lumbar epidural technique for labor analgesia requires technical training and a manual skillset. A prior study evaluating anesthesia resident learning curves for a traditional labor epidural technique demonstrated a steep learning curve for the first 20 epidural placements, followed by a plateau with gradual proficiency maximized after 60 epidural placements (1). A prior study evaluated a spring-loaded epidural syringe among experienced providers (2). However, the impact of a spring-loaded epidural syringe on novice anesthesia resident learning curves is unknown. In addition, the impact of EpiFaith® use at the time of manual skill acquisition on success with subsequent traditional epidural technical skills is unknown.
The EpiFaith® syringe is FDA-cleared and has a spring-loaded piston designed to detect entry into the epidural space upon loss of resistance (LOR) as the epidural needle tip moves from the dense ligamentum flavum to the high-compliance epidural space. Performing the LOR technique using the EpiFaith® syringe, the piston within the syringe moves forward driven by spring force when a drop in pressure is detected. Piston movement within the syringe is visibly detectable with a yellow indicator in the syringe when LOR occurs. In a feasibility study of 40 labor epidural placements, 3 of 4 expert obstetric anesthesiology physicians reported the EpiFaith® syringe to be equal to superior in quality to the standard LOR syringe, with 100% success rate and no inadvertent dural punctures (3).
Evaluating the impact of the EpiFaith® syringe on learning curves of anesthesia residents with minimal prior technical experience will help inform how we approach education regarding the labor epidural technique. Steeper learning curves with faster time to proficiency may benefit both patients and supervising staff, while if no difference is determined, the use of the EpiFaith® syringe can be de-emphasized during the training period.
- Being tested
- EpiFaith epidural syringe, Control (glass) syringe
- Keywords
- labor epidural, learning curve, epidural syringe, anesthesia residents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiFaith epidural syringeDevice
The EpiFaith syringe is an FDA-cleared epidural syringe.
Control (glass) syringeDevice
glass epidural syringe
| Study group | Role | What they receive |
|---|---|---|
| Control (glass epidural syringe) | Experimental | Not described Receives: Device: Control (glass) syringe |
| EpiFaith syringe | Experimental | Not described Receives: Device: EpiFaith epidural syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of labor epidural attempt
success of labor epidural attempt over time by each resident, with success defined as a composite requiring:
- Less than 3 attempts for placement
- No need to re-site the epidural needle
- No staff intervention
- NRS 3 or less at 30 minutes post-loading epidural dose
Measured: time of epidural placement to 30 minutes after dosing of the epidural
Secondary outcomes (4)
rating of the epidural syringe
rating of the epidural syringe loss of resistance technique
Measured: from time of placement to immediately following placement
Incidence of inadvertent dural puncture
incidence of inadvertent dural puncture
Measured: from time of epidural placement for a maximum of 5 days
incidence of postdural puncture headache
incidence of postdural puncture headache
Measured: from time of epidural placement up to 5 days
Need for epidural catheter replacement during labor
need for epidural catheter replacement during labor
Measured: from time of epidural placement through delivery during hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Sep 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnalgesiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- The study will be conducted as a quasi-eperimental trial. Study subjects will be assigned to one of the two groups for their epidural placement based on the month of their rotation, with alternating months: 1) EpiFaith® Group, in which EpiFaith® syringe is used; or 2) Control Group in which a conventional glass syringe is used
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michaela Kristina Farber, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395622
- Sponsor's protocol ID
- 2023P001926
- Other IDs
- 2023A006350
- Status last verified
- Aug 2026
- First submitted
- 17 Jan 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the EpiFaith® Syringe on the Learning Curve of Anesthesia Residents for the Labor Epidural Technique: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07395622
- Acronym / sponsor ID
- 2023P001926
- Keywords
- labor epidural, learning curve, epidural syringe, anesthesia residents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Feb 2026 (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.
This study aims to evaluate the impact of the EpiFaith® syringe on the learning curve of anesthesia residents for the labor epidural technique. Anesthesia residents with prior experience placing \< 5 labor epidurals will be enrolled. Their performance of 20 sequential labor epidural placements with either standard technique with a beveled glass syringe or the EpiFaith® syringe will be observed. Successful epidural placement over time with sequential epidural placement attempts will be measured between groups. The primary outcome will be rate of successful epidural placement. Success will be defined as a composite of 4 criteria: maximum 3 attempts for placement; no need to re-site at a different level; no required intervention by the supervising attending anesthesiologist; and adequate analgesia with a visual analog score (VAS) \<3 at 30 minutes. We hypothesize that use of the EpiFaith® syringe will enable a faster learning curve for successful epidural placement. A cumulative sum chart (CUSUM) analysis will evaluate whether the EpiFaith® syringe causes deviation from the control learning curve. Secondary outcomes will include rate of inadvertent dural puncture and epidural replacement rate.
Detailed description
The lumbar epidural technique for labor analgesia requires technical training and a manual skillset. A prior study evaluating anesthesia resident learning curves for a traditional labor epidural technique demonstrated a steep learning curve for the first 20 epidural placements, followed by a plateau with gradual proficiency maximized after 60 epidural placements (1). A prior study evaluated a spring-loaded epidural syringe among experienced providers (2). However, the impact of a spring-loaded epidural syringe on novice anesthesia resident learning curves is unknown. In addition, the impact of EpiFaith® use at the time of manual skill acquisition on success with subsequent traditional epidural technical skills is unknown.
The EpiFaith® syringe is FDA-cleared and has a spring-loaded piston designed to detect entry into the epidural space upon loss of resistance (LOR) as the epidural needle tip moves from the dense ligamentum flavum to the high-compliance epidural space. Performing the LOR technique using the EpiFaith® syringe, the piston within the syringe moves forward driven by spring force when a drop in pressure is detected. Piston movement within the syringe is visibly detectable with a yellow indicator in the syringe when LOR occurs. In a feasibility study of 40 labor epidural placements, 3 of 4 expert obstetric anesthesiology physicians reported the EpiFaith® syringe to be equal to superior in quality to the standard LOR syringe, with 100% success rate and no inadvertent dural punctures (3).
Evaluating the impact of the EpiFaith® syringe on learning curves of anesthesia residents with minimal prior technical experience will help inform how we approach education regarding the labor epidural technique. Steeper learning curves with faster time to proficiency may benefit both patients and supervising staff, while if no difference is determined, the use of the EpiFaith® syringe can be de-emphasized during the training period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted as a quasi-eperimental trial. Study subjects will be assigned to one of the two groups for their epidural placement based on the month of their rotation, with alternating months: 1) EpiFaith® Group, in which EpiFaith® syringe is used; or 2) Control Group in which a conventional glass syringe is used
| Arm | Type | Receives |
|---|---|---|
| Control (glass epidural syringe) | Experimental | Device: Control (glass) syringe |
| EpiFaith syringe | Experimental | Device: EpiFaith epidural syringe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesiology residents with fewer than 5 prior epidural placement experiences
Key exclusion criteria (1 listed)
- anesthesiology residents with more than 5 prior epidural placement experiences
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 |
|---|---|---|
| EpiFaith epidural syringeThe EpiFaith syringe is an FDA-cleared epidural syringe. | Device | EpiFaith syringe |
| Control (glass) syringeglass epidural syringe | Device | Control (glass epidural syringe) |
Primary outcome
success of labor epidural attempt
Time frame: time of epidural placement to 30 minutes after dosing of the epidural
success of labor epidural attempt over time by each resident, with success defined as a composite requiring: 1. Less than 3 attempts for placement 2. No need to re-site the epidural needle 3. No staff intervention 4. NRS 3 or less at 30 minutes post-loading epidural dose
4 secondary outcomes
rating of the epidural syringe
Time frame: from time of placement to immediately following placement
Incidence of inadvertent dural puncture
Time frame: from time of epidural placement for a maximum of 5 days
incidence of postdural puncture headache
Time frame: from time of epidural placement up to 5 days
Need for epidural catheter replacement during labor
Time frame: from time of epidural placement through delivery during hospital admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Postpartum Urinary Retention
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Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
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Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiFaith epidural syringe in people with Epidural Analgesia and Epidural Analgesia for Labour and Delivery, run by Brigham and Women's Hospital at 1 site in United States.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaela K Farber, MD MS (617-759-1609, mfarber@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of labor epidural attempt (time frame: time of epidural placement to 30 minutes after dosing of the epidural). 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 21 Aug 2026.