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NCT02949271 · ClinicalTrials.gov registry record · Phase 4
Comparison of PIEB vs CEI for Labor Analgesia
A Phase 4 study of Labor Pain, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 179
- Enrollment target
- 1
- Study location
NCT02949271: Completed Phase 4 study of Labor Pain, sponsored by Duke University.
NCT02949271 is a Phase 4 study of Labor Pain that has completed, run by Duke University. The registered enrollment target is 179 participants, roughly in line with the 191-participant average among 14 other Labor Pain trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02949271, a Phase 4 study of Labor Pain, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 179 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this prospective, doubled-blinded randomized study is to compare two modes of epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing, for providing labor epidural analgesia. The primary outcome will be the volume of local anesthetic received through PCEA. Secondary outcomes will measure time to first PCEA bolus, labor pain scores, degree of motor blockade, mode of delivery, PCEA attempts and ratio of successful to unsuccessful attempts, frequency of hypotension, duration of first and second stages of labor and level of patient satisfaction. The investigator plans to enroll 120 nulliparous participants at 2-5 com cervical dilation, with 60 patients to each arm. The subject will be assigned to receive either delivery of epidural medication ropivacaine 0.1% with fentanyl 2mcg/mL with PIEB + PCEA dosing method or CEI + PCEA. Continuous data will be analyzed using the Kruskal-Wallis test or t-test as appropriate. Categorical data will be analyzed using Chi-square test or Fisher's exact test as appropriate.
Primary Outcome
The volume of local anesthetic that the patient received through activation of the patient-controlled epidural analgesia system per hour.
Conditions Studied
Interventions
- DRUG Ropivacaine
- DRUG Fentanyl
- OTHER Programmed Intermittent Epidural Bolus
- OTHER Continuous Epidural Infusion
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2016-11-08 |
| Est. Completion | 2017-11-01 |
| Phase | Phase 4 |
What the finished NCT02949271 record still lists
NCT02949271 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 191-participant average among 14 other Labor Pain trials with a reported enrollment target.
The record links to 1 condition, with Labor Pain appearing as the primary indexed condition, and to 4 interventions - of which Ropivacaine is the first listed.
NCT02949271 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02949271 about?
NCT02949271 is a clinical study titled "Comparison of PIEB vs CEI for Labor Analgesia". The aim of this prospective, doubled-blinded randomized study is to compare two modes of epidural analgesia delivery, programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI) with patient controlled epidural analgesia (PCEA) dosing, for providing labor epidural analg...
What is the current status of trial NCT02949271?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 179 participants. The study started on 2016-11-08. Estimated completion is 2017-11-01.
What conditions does trial NCT02949271 study?
This clinical trial studies the following conditions: Labor Pain.
What interventions are being tested in trial NCT02949271?
The interventions under investigation include: Ropivacaine (DRUG), Fentanyl (DRUG), Programmed Intermittent Epidural Bolus (OTHER), Continuous Epidural Infusion (OTHER).
Who is sponsoring clinical trial NCT02949271?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02949271 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Labor Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02949271's enrollment target sits among peer trials
179 5th of 14 higher than 10 of 14 other Labor Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Labor Pain 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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