Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04198662 · ClinicalTrials.gov registry record · Phase 4
Rib Fracture Analgesia Using Cryoanalgesia
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT04198662 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 20 participants.
The verdict
NCT04198662, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 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 pulmonary complications and a high degree of morbidity and mortality. Peripheral nerve blocks as well as epidural blocks have been used with success to improve pain control in rib fracture patients and have been associated with decreased pulmonary complications and improved outcomes. However, a single-injection nerve block lasts less than 24 hours; and, even a continuous nerve block is generally limited to 3-4 days. The pain from rib fractures usually persists for multiple weeks or months. In contrast to local anesthetic-induced nerve blocks, a prolonged block lasting a few weeks/months may be provided by freezing the nerve using a process called "cryoneurolysis". The goal of this multicenter, randomized, double-masked, sham-controlled, parallel-arm study is to evaluate the potential of cryoanalgesia to decrease pain and improve pulmonary mechanics in patients with rib fractures.
Interventions
- DEVICE Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas)
- DRUG Intercostal nerve block ropivacaine with epinephrine
- DEVICE Sham cryoneurolysis with a Painblocker
- DRUG Placebo intercostal nerve block with normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-04-03 |
| Est. Completion | 2024-08-27 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04198662
The ClinicalTrials.gov registry entry for NCT04198662 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 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 4 interventions - of which Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas) is the first listed.
NCT04198662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04198662 about?
NCT04198662 is a clinical study titled "Rib Fracture Analgesia Using Cryoanalgesia". 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 pulmonary complications and a high degree of morbidity and mortality. Periphe...
What is the current status of trial NCT04198662?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-04-03. Estimated completion is 2024-08-27.
What interventions are being tested in trial NCT04198662?
The interventions under investigation include: Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas) (DEVICE), Intercostal nerve block ropivacaine with epinephrine (DRUG), Sham cryoneurolysis with a Painblocker (DEVICE), Placebo intercostal nerve block with normal saline (DRUG).
Who is sponsoring clinical trial NCT04198662?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.