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NCT04413799 · ClinicalTrials.gov registry record · Early Phase 1
PVB vs Ketamine/Lidocaine in Rib Fracture Patients
A Early Phase 1 study, sponsored by George Washington University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 32
- Enrollment target
NCT04413799: Clinical Trial Early Phase 1 study, sponsored by George Washington University.
NCT04413799 is a Early Phase 1 study that was terminated before completion, run by George Washington University. The registered enrollment target is 32 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04413799, a Early Phase 1 study, was terminated before completion, sponsored by George Washington University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
Rib fractures are a common admission to the trauma service. The mainstay of treatment is pain control to improve respiratory effort in order to offset the risk of pneumonia and mechanical ventilation. In addition to standard pain control modalities, the investigator's institution utilizes paravertebral blocks as well as lidocaine and ketamine infusions for pain control. The current standard of care for pain control is to begin with acetaminophen, ibuprofen or celecoxib and opioids with the addition of paravertebral blocks as needed. In certain situations, a paravertebral block is contraindicated, and pain control is relegated to lidocaine and ketamine infusion. The use of lidocaine infusion alone and ketamine infusion alone for pain control has been studied and has been shown to be safe. However, concurrent use of these two medications to control rib fracture pain is relatively new and the efficacy compared to paravertebral block is not known. The goal of the study is to show non-inferiority of simultaneous lidocaine and ketamine infusions versus paravertebral blocks.
Primary Outcome
Numeric pain score is a scale of 1- 10 to ascertain patient's subjective pain severity. Patients will be asked their NPS daily.
Interventions
- COMBINATION_PRODUCT lidocaine, ketamine intravenous infusion
- DRUG paravertebral block with ropivicaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2025-01-01 |
| Phase | Early Phase 1 |
Why NCT04413799 stopped before completion
NCT04413799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which lidocaine, ketamine intravenous infusion is the first listed.
NCT04413799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04413799 about?
NCT04413799 is a clinical study titled "PVB vs Ketamine/Lidocaine in Rib Fracture Patients". Rib fractures are a common admission to the trauma service. The mainstay of treatment is pain control to improve respiratory effort in order to offset the risk of pneumonia and mechanical ventilation. In addition to standard pain control modalities, the investigator's institution utilizes paraverteb...
What is the current status of trial NCT04413799?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2020-09-01. Estimated completion is 2025-01-01.
What interventions are being tested in trial NCT04413799?
The interventions under investigation include: lidocaine, ketamine intravenous infusion (COMBINATION_PRODUCT), paravertebral block with ropivicaine (DRUG).
Who is sponsoring clinical trial NCT04413799?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04413799's enrollment target sits among peer trials
32 775th of 2000 higher than 1,207 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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