EpiFaith Resident Learning Curve Trial
Brigham and Women's Hospital · NCT07395622
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 34
- US sites recruiting
- 1
- Study start
- September 1, 2023
- Record last updated
- August 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: EpiFaith epidural syringe; Control (glass) syringe
Conditions: Epidural Analgesia; Epidural Analgesia for Labour and Delivery; Learning Curve
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Anesthesiology residents with fewer than 5 prior epidural placement experiences
Exclusion Criteria
- anesthesiology residents with more than 5 prior epidural placement experiences
Recruiting US locations
Brigham and Women's Hospital
Boston, MA 02115
Site contact: Michaela K Farber, MD MS · 617-759-1609 · mfarber@bwh.harvard.edu
Study contacts (from the official record)
- Michaela K Farber, MD MS · 617-759-1609 · mfarber@bwh.harvard.edu
- Noor A Raheel, MD · 617-732-8251 · nraheel@bwh.harvard.edu
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