NCT07032766 · Albert Einstein College of Medicine
Assessment of Morbidity and Mortality Following Serratus Anterior Plane Block (SAPB) for Unilateral Rib Fractures
(SAPB)
What this study is about
The goal of this observational study is to learn about the long-term effects of the serratus anterior plane block (SAPB) in adult patients who suffered multiple unilateral anterolateral rib fractures within 24 hours of patient presentation to the emergency department.
View original scientific description
The goal of this observational study is to learn about the long-term effects of the serratus anterior plane block (SAPB) in adult patients who suffered multiple unilateral anterolateral rib fractures within 24 hours of patient presentation to the emergency department. The main question it aims to answer is: Does the SAPB for multiple anterolateral rib fractures demonstrate reduction in patient morbidity and mortality, including incidence of pneumonia, length of hospital stay, discharge disposition, and death, as compared to standard analgesic regimens. The SAPB will be performed if a physician trained in the SAPB is available within 24 hours of injury. If a trained physician is not available and the patient meets inclusion criteria, they will receive parental analgesia with opioid therapy. They will be followed until date of hospital discharge, up until 60 days.
Primary outcome measures
Number of Patients with Hospital Acquired Pneumonia (HAP) Events
Time frame: From time of ED arrival until hospital discharge, up until 90 days
The number of patients of hospital acquired pneumonia events will be summarized by study arm/group using basic descriptive statistics.
Days of Hospital Length of Stay
Time frame: ED arrival to hospital discharge, up until 90 days
For purposes of this study, length of hospital stay will be defined as the total duration of admission and will be recorded in total number of days (from ED admission to discharge) and summarized by study arm/group using basic descriptive statistics. Discharge may include to acute rehabilitation (located in the hospital but not considered in calculation for length of stay).
Discharge Disposition
Time frame: ED admission to discharge , up until 90 days
Discharge Disposition will encompass the location to which the patient is discharged (i.e., home, home with Physical Therapy (PT), subacute rehabilitation, acute rehabilitation, or deceased). Disposition types will be categorically itemized and summarized by study arm/group.
Length of stay (Days) in the Intensive Care Unit (ICU)
Time frame: ED admission to hospital discharge, up until 90 days
For purposes of this study, ICU length of stay will be defined as the total number of days of admission to an ICU and will be summarized by study arm/group using basic descriptive statistics. If a patient is discharged from the ICU and subsequently returns to the ICU, the total duration of admission will be aggregated.
Cause of death
Time frame: ED admission until hospital discharge, up until 90 days
If a patient is "discharged as deceased" (see prior outcome measure) the cause of death will be recorded, if known, and summarized by study arm/group.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients over 18 years of age being treated in the Emergency Department at Jacobi Medical Center
- Presenting within 24 hours of injury
- Patient with 2 or more unilateral, anterior or lateral rib fractures
- Able to provide consent (patient or health care proxy)
- Clinical team believes the patient will require inpatient admission at the time of enrollment
Exclusion criteria
- Patients in traumatic arrest or hemodynamic instability
- Patient expected to be discharged from the hospital within 24 hours
- Children less than 18 years of age
- The patient is known or is suspected to be allergic to anesthetic
- Significant pain from another traumatic and distracting injury
- Patients without the ability to consent (or no health care proxy to consent)
- Patients with bilateral or posterior rib fractures
Where
- The Bronx, New York
Collaborators
Jacobi Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2025 · Source of record for eligibility and locations