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NCT04530149 · ClinicalTrials.gov registry record · Phase 4
Vital Capacity in Ultrasound Guided Serratus Plane Block in ED Patients With Multiple Rib Fractures
A Phase 4 study, sponsored by Antonios Likourezos.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT04530149: Clinical Trial Phase 4 study, sponsored by Antonios Likourezos.
NCT04530149 is a Phase 4 study that was terminated before completion, run by Antonios Likourezos. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04530149, a Phase 4 study, was terminated before completion, sponsored by Antonios Likourezos.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
I. Background: Patients with multiple rib fractures are challenging from both pulmonary and analgesia perspectives. Adequate pain management is essential in prevention of complications secondary to decreased inspiratory volume. Significant morbidity and mortality of rib fractures is secondary to severe pain that limits ribcage movement, decreases inspiratory volumes and causes inadequate cough. Decreased vital capacity predisposes patients to atelectasis, abnormal mucous clearance and pneumonia. The objective of this study is to assess the efficacy of the serratus anterior plane block (SAPB) in improvement of vital capacity in patients with multiple unilateral rib fractures when compared to conventional management with medications. Currently, evidence of efficacy of SAPB in managing pain secondary to multiple rib fractures is limited to case reports and series, none of which evaluate vital capacity. II. Significance: The findings of this study may indicate that SAPB is superior to pharmacological management in increasing vital capacity in patients with multiple unilateral rib fractures and suggest SAPB for first line therapy in patients with rib fractures. The findings may decrease the risk of pulmonary complications as well as the use of opiates in management of multiple rib fractures in the Emergency Department especially in patients with numerous comorbidities and contraindications to conventional treatment modalities. This study may support the need for training emergency medicine physicians in bedside SAPB in order to provide the optimal therapy for patient with multiple unilateral rib fractures. III. Study Objectives: The primary objectives are to evaluate whether ultrasound guided SAPB results in a greater improvement in percent predicted vital capacity compared to standard therapy with a sham injection. The investigators will also evaluate pain scores and the safety profile of the SAPB procedure compared to those receiving standard analgesia. IV. Hypot
Primary Outcome
Pain score on 11 point Numeric Rating Scale ranging 0-10 with 0 being no pain, 5 being moderate pain, and 10 being very severe pain
Interventions
- DRUG Acetaminophen
- DRUG Bupivacain
- DRUG Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2024-03-04 |
| Phase | Phase 4 |
Why NCT04530149 stopped before completion
NCT04530149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Acetaminophen is the first listed.
NCT04530149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04530149 about?
NCT04530149 is a clinical study titled "Vital Capacity in Ultrasound Guided Serratus Plane Block in ED Patients With Multiple Rib Fractures". I. Background: Patients with multiple rib fractures are challenging from both pulmonary and analgesia perspectives. Adequate pain management is essential in prevention of complications secondary to decreased inspiratory volume. Significant morbidity and mortality of rib fractures is secondary to se...
What is the current status of trial NCT04530149?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2021-11-01. Estimated completion is 2024-03-04.
What interventions are being tested in trial NCT04530149?
The interventions under investigation include: Acetaminophen (DRUG), Bupivacain (DRUG), Saline (DRUG).
Who is sponsoring clinical trial NCT04530149?
This trial is sponsored by Antonios Likourezos, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04530149's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 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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