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NCT05068661 · ClinicalTrials.gov registry record · Phase 4
Comparing Effectiveness of CSE Versus DPE for Labor Analgesia
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 101
- Enrollment target
NCT05068661: Completed Phase 4 study, sponsored by Duke University.
NCT05068661 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 101 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05068661, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 101 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine if there are differences in block quality between the CSE and DPE techniques for labor analgesia in parturients in active labor. We hypothesize that when compared to the CSE technique, the DPE technique will significantly improve block quality in this population and require fewer "top-ups" and catheter replacements.
Primary Outcome
The primary outcome of this study is block quality which will be defined by a composite of five components (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring general anesthesia or replacement neuraxial anesthesia for cesarean section. The presence of any of the components (or more than one) indicates that the outcome occurred.
Interventions
- DRUG Bupivacaine 0.25% Injectable Solution
- DRUG Ropivacaine 0.1% Injectable Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-11-21 |
| Est. Completion | 2023-12-07 |
| Phase | Phase 4 |
What the finished NCT05068661 record still lists
NCT05068661 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine 0.25% Injectable Solution is the first listed.
NCT05068661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05068661 about?
NCT05068661 is a clinical study titled "Comparing Effectiveness of CSE Versus DPE for Labor Analgesia". The primary purpose of this study is to determine if there are differences in block quality between the CSE and DPE techniques for labor analgesia in parturients in active labor. We hypothesize that when compared to the CSE technique, the DPE technique will significantly improve block quality in thi...
What is the current status of trial NCT05068661?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 101 participants. The study started on 2021-11-21. Estimated completion is 2023-12-07.
What interventions are being tested in trial NCT05068661?
The interventions under investigation include: Bupivacaine 0.25% Injectable Solution (DRUG), Ropivacaine 0.1% Injectable Solution (DRUG).
Who is sponsoring clinical trial NCT05068661?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05068661's enrollment target sits among peer trials
101 766th of 2000 higher than 1,231 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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