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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 is a Phase 4 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 146 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03553576
The ClinicalTrials.gov registry entry for NCT03553576 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low volume bolus is the first listed.
NCT03553576 reports 0 study locations.
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.
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