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NCT03553576 · ClinicalTrials.gov registry record · Phase 4
Drug Concentration and Volume on Adequate Labor Analgesia With PIEB
A Phase 4 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 146
- Enrollment target
NCT03553576: Clinical Trial Phase 4 study, sponsored by Northwestern University.
NCT03553576 is a Phase 4 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 146 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03553576, a Phase 4 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 146 participants
- Enrollment target
Study Summary
Neuraxial labor analgesia is performed by the administration of a local anesthetic/opioid mixture in the epidural space. The delivery method is a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia \[PCEA\]) via epidural catheter. The anesthetic solution administered through the lumbar epidural catheter must spread cephalad in the epidural space to reach the T10 nerve roots and spinal cord, and must spread caudad to reach the caudal nerve roots in the epidural space. Epidural infusion pumps capable of delivering PIEB of local anesthetic with PCEA have become commercially available and many studies have attempted to assess the optimal parameter settings (including volume of programmed bolus, bolus interval, rate of bolus administration) to provide superior labor analgesia. Traditionally higher concentration local anesthetic solutions have been associated with increased motor blockade leading to a higher incidence of instrumental vaginal delivery. Several local anesthetic solutions with varying drug concentrations are available for labor analgesia and are used clinically in the United States. We plan to perform a randomized, controlled, double-blind study to test the hypothesis that patients whose labor analgesia is maintained using PIEB with low-volume bolus (6.25 mL) of a higher local anesthetic concentration solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) will require less supplemental analgesia (manual provider re-doses) than patients whose PIEB is delivered with a high-volume bolus (10 mL) of lower density local anesthetic solution (0.0625% bupivacaine with fentanyl 2.0 mcg/mL). The aim of this study is to evaluate the association between bolus volume and concentration of local anesthetic during maintenance of labor analgesia with programmed intermittent epidural bolus (PIEB) analgesia. The hypothesis of this study is: patients whose labor analgesia is maintained using
Primary Outcome
Anesthesia provider (MD) administered boluses of additional anesthetic administered prior to the delivery of the baby.
Interventions
- DRUG Low volume bolus
- DRUG High volume bolus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2020-01-21 |
| Est. Completion | 2023-06-01 |
| Phase | Phase 4 |
Why NCT03553576 stopped before completion
NCT03553576 is an interventional study that assigns participants to a tested intervention. The registered 146 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 (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Low volume bolus is the first listed.
NCT03553576 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03553576 about?
NCT03553576 is a clinical study titled "Drug Concentration and Volume on Adequate Labor Analgesia With PIEB". Neuraxial labor analgesia is performed by the administration of a local anesthetic/opioid mixture in the epidural space. The delivery method is a combination of continuous infusion, provider-administered boluses and patient-administered boluses (patient controlled epidural analgesia \[PCEA\]) via ep...
What is the current status of trial NCT03553576?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 146 participants. The study started on 2020-01-21. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT03553576?
The interventions under investigation include: Low volume bolus (DRUG), High volume bolus (DRUG).
Who is sponsoring clinical trial NCT03553576?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03553576's enrollment target sits among peer trials
146 571st of 2000 higher than 1,428 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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