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Recruiting NCT07395622

EpiFaith Resident Learning Curve Trial

Conditions: Epidural Analgesia, Epidural Analgesia for Labour and Delivery, Learning Curve

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 34
Sponsor: Brigham and Women's Hospital

Location: Brigham and Women's Hospital Boston Massachusetts

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. 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.

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07395622). StuddyBuddy aggregates publicly available trial information.