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-SAPB
    Patients 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

Locations (1)

FacilityCityStateZIPSite coordinators
Jacobi Medical CenterThe BronxNew York10461
Ariella Gartenberg, MD
201-787-1762
Michelle Montenegro, MD (PRINCIPAL_INVESTIGATOR)

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