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NCT04558281 · ClinicalTrials.gov registry record · Phase 4
Continuous Erector Spinae Plane Blocks for Rib Fractures
A Phase 4 study, sponsored by University of California, San Diego.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT04558281 is a Phase 4 study that was terminated before completion, run by University of California, San Diego. The registered enrollment target is 4 participants.
The verdict
NCT04558281, a Phase 4 study, was terminated before completion, sponsored by University of California, San Diego.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further injury and even death. One recent study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection Erector Spainae Plane Block (ESPB) while pain levels nearly halved. However, a single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion (also termed a "continuous peripheral nerve block") may be administered for multiple days. This entails inserting a tiny tube through the skin and into the area around the nerves, after which more local anesthetic may be administered prolonging the numbing effects. The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated. We therefore are conducting a randomized, triple-masked, placebo-controlled, parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fractures. The primary outcome of this study will be the maximum inspired volume measured by incentive spirometry on the afternoon following the nerve block procedure. We hypothesize that the maximum inspired volume will be significantly increased in the afternoon following the procedure with the addition of a continuous ESPB to a single-injection ESPB.
Interventions
- DRUG Active ropivacaine 0.3% erector spinae plane perineural administration
- DRUG Placebo erector spinae plane perineural administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-05-23 |
| Est. Completion | 2023-03-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04558281
The ClinicalTrials.gov registry entry for NCT04558281 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Active ropivacaine 0.3% erector spinae plane perineural administration is the first listed.
NCT04558281 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04558281 about?
NCT04558281 is a clinical study titled "Continuous Erector Spinae Plane Blocks for Rib Fractures". Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further inju...
What is the current status of trial NCT04558281?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2021-05-23. Estimated completion is 2023-03-24.
What interventions are being tested in trial NCT04558281?
The interventions under investigation include: Active ropivacaine 0.3% erector spinae plane perineural administration (DRUG), Placebo erector spinae plane perineural administration (DRUG).
Who is sponsoring clinical trial NCT04558281?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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