Assessment of Morbidity and Mortality Following Serratus Anterior Plane Block (SAPB) for Unilateral Rib Fractures
Part of paid clinical trials in The Bronx, New York.
- Sponsor
- Albert Einstein College of Medicine
- Study ID
- NCT07032766
- Status
- Recruiting
Conditions
- Pain Management
- Rib Fracture Multiple
- Serratus Anterior Plane Block
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Aug 10, 2025
- Status verified
- Aug 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 220 participants (estimated)
Arms
- Arm: Serratus Anterior Plane Block (SAPB)Following visualization of the serratus anterior muscle, the latissimus dorsi muscle, and the pleural line, and creating a skin wheel at the puncture site, a 22-gauge 3.5 or 4 inch echogenic PAJUNK® SonoBlock II needle will be inserted just lateral to the transducer at 45 degrees. The needle will be visualized in-plane under real time ultrasound guidance to ensure correct placement between the latissimus dorsi and serratus anterior muscle. 20 ml of bupivacaine hydrochloride 0.25% will be infiltrated into the superficial plane and local anesthetic spread will be observed on ultrasound. Ultrasound images will be obtained pre-procedure, during, and post procedure to demonstrate that the needle tip is away from the pleura and appropriate hydrodissection of muscle fascia occurs.
- Arm: Non-SAPBPatients in this arm will receive IV analgesia, mainly opioid therapy.
Primary Outcome Measure
Number of Patients with Hospital Acquired Pneumonia (HAP) Events [ Time Frame: From time of ED arrival until hospital discharge, up until 90 days ]
Central Contacts
- Ariella Gartenberg, MD2017871762
- Michelle Montenegro, MD7189185800
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Jacobi Medical Center | The Bronx | New York | 10461 | Michelle Montenegro, MD (PRINCIPAL_INVESTIGATOR) |
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