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NCT03414359 · ClinicalTrials.gov registry record · Early Phase 1
Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery
A Early Phase 1 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 70
- Enrollment target
NCT03414359: Completed Early Phase 1 study, sponsored by University of Arkansas.
NCT03414359 is a Early Phase 1 study that has completed, run by University of Arkansas. The registered enrollment target is 70 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03414359, a Early Phase 1 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
Regional anesthesia is commonly used for elective and emergency cesarean delivery. It provides numerous safety advantages when compared to general anesthesia for both the mother and fetus1. Epidurals also have the added benefit of being able to provide pain relief throughout labor and in the event of cesarean delivery, epidural analgesia can be "extended" to provide surgical anesthesia. Numerous studies have been performed to assess the onset times of various local anesthetics when administered through an epidural catheter. Attempts to reduce anesthetic onset time and improve the quality of intraoperative analgesia have been attempted by using different local anesthetic solutions and by the addition of other drugs to the epidural solution (such as epinephrine, fentanyl and sodium bicarbonate).
Primary Outcome
The onset time to surgical anesthesia, as reported by the participant using a standard procedure This will be measured by the time taken from the end of the epidural loading dose to develop a loss of touch sensation using a neurotip® (Owen Mumford, USA) device bilaterally at the T7 dermatomal level using a non-inferiority study design. A non-inferiority limit of 3 minutes was chosen apriori.
Interventions
- DRUG 2% Lidocaine
- DRUG 3% Chloroprocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2018-02-15 |
| Est. Completion | 2019-03-27 |
| Phase | Early Phase 1 |
What the finished NCT03414359 record still lists
NCT03414359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 2 interventions - of which 2% Lidocaine is the first listed.
NCT03414359 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03414359 about?
NCT03414359 is a clinical study titled "Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery". Regional anesthesia is commonly used for elective and emergency cesarean delivery. It provides numerous safety advantages when compared to general anesthesia for both the mother and fetus1. Epidurals also have the added benefit of being able to provide pain relief throughout labor and in the event o...
What is the current status of trial NCT03414359?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 70 participants. The study started on 2018-02-15. Estimated completion is 2019-03-27.
What interventions are being tested in trial NCT03414359?
The interventions under investigation include: 2% Lidocaine (DRUG), 3% Chloroprocaine (DRUG).
Who is sponsoring clinical trial NCT03414359?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03414359's enrollment target sits among peer trials
70 339th of 2000 higher than 1,646 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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