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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: Completed Phase 4 study, sponsored by University of California, San Diego.
NCT04198662 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
maximum inspired volume measured on a handheld incentive spirometer based on the American Association of Respiratory Care (AARC) clinical practice guideline.\[Restrepo. Respirated Care 2011\] The best of three measurements will be recorded as the maximum inspired volume.
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 |
What the finished NCT04198662 record still lists
NCT04198662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
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 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04198662's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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