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NCT01005459 · ClinicalTrials.gov registry record · Phase 4
Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE
A Phase 4 study, sponsored by Wake Forest University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT01005459: Clinical Trial Phase 4 study, sponsored by Wake Forest University.
NCT01005459 is a Phase 4 study that was terminated before completion, run by Wake Forest University. The registered enrollment target is 46 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01005459, a Phase 4 study, was terminated before completion, sponsored by Wake Forest University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study Summary
The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.
Primary Outcome
duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete
Interventions
- DRUG Bupivacaine
- DRUG Tetracaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-12-12 |
| Phase | Phase 4 |
Why NCT01005459 stopped before completion
NCT01005459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine is the first listed.
NCT01005459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01005459 about?
NCT01005459 is a clinical study titled "Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE". The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when ana...
What is the current status of trial NCT01005459?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2009-08. Estimated completion is 2011-12-12.
What interventions are being tested in trial NCT01005459?
The interventions under investigation include: Bupivacaine (DRUG), Tetracaine (DRUG).
Who is sponsoring clinical trial NCT01005459?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01005459's enrollment target sits among peer trials
46 1348th of 2000 higher than 647 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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