Vital Capacity in Ultrasound Guided Serratus Plane Block in ED Patients With Multiple Rib Fractures
Public ClinicalTrials.gov record NCT04530149. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Vital Capacity in Ultrasound Guided Serratus Plane Block in Emergency Department Patients With Multiple Rib Fractures: A Randomized Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. Hypothesis: The primary hypothesis is that SAPB is superior to sham injection in improving the percent of predicted vital capacity. The secondary hypothesis is that SAPB will have greater improvement in pain scores and have a superior safety profile compared to placebo injection.
Study identification
- NCT ID
- NCT04530149
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 3 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 120 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2021
- Primary completion
- Mar 3, 2024
- Completion
- Mar 3, 2024
- Last update posted
- Jun 10, 2024
2021 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04530149, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04530149 live on ClinicalTrials.gov.