Assessment of Morbidity and Mortality Following Serratus Anterior Plane Block (SAPB) for Unilateral Rib Fractures

NCT07032766 | Recruiting DMC

• 1 other identifier: 2024-16493
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management; Rib Fracture Multiple; Serratus Anterior Plane Block

Keywords

serratus anterior plane block; rib fractures; mortality; morbidity

Outcome Measures

Primary Outcomes (5)

• Number of Patients with Hospital Acquired Pneumonia (HAP) Events

  The number of patients of hospital acquired pneumonia events will be summarized by study arm/group using basic descriptive statistics.

  From time of ED arrival until hospital discharge, up until 90 days

• Days of Hospital Length of Stay

  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).

  ED arrival to hospital discharge, up until 90 days

• Discharge Disposition

  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.

  ED admission to discharge , up until 90 days

• Length of stay (Days) in the Intensive Care Unit (ICU)

  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.

  ED admission to hospital discharge, up until 90 days

• Cause of death

  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.

  ED admission until hospital discharge, up until 90 days

Secondary Outcomes (2)

• Pain Intensity

  Baseline (initial evaluation) and 30 and 60 minutes after SAPB is performed

• Number of patients per group that required additional analgesia

  Up until 24 hours after the initial block or IV opioid medication administration

Study Arms (2)

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.

Non-SAPB

Patients in this arm will receive IV analgesia, mainly opioid therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include a cohort of patients presenting within 24 hours of injury with two or more unilateral, anterior or lateral rib fractures requiring opioid analgesia that would be admitted to the trauma service at a single urban level 1 trauma center. The authors anticipate recruitment of 200 participants over the course of a study duration of 1 year.

You may qualify if:

• 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

You may not qualify if:

• Patients in traumatic arrest or hemodynamic instability
• Patient expected to be discharged from the hospital within 24 hours
• Prisoner
• Pregnancy
• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Jacobi Medical Center: collaborator

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (14)

• Lin J, Hoffman T, Badashova K, Motov S, Haines L. Serratus Anterior Plane Block in the Emergency Department: A Case Series. Clin Pract Cases Emerg Med. 2020 Jan 21;4(1):21-25. doi: 10.5811/cpcem.2019.11.44946. eCollection 2020 Feb.

  PMID: 32064417 BACKGROUND

• Schnekenburger M, Mathew J, Fitzgerald M, Hendel S, Sekandarzad MW, Mitra B. Regional anaesthesia for rib fractures: A pilot study of serratus anterior plane block. Emerg Med Australas. 2021 Oct;33(5):788-793. doi: 10.1111/1742-6723.13724. Epub 2021 Jan 29.

  PMID: 33511786 BACKGROUND

• Serra S, Santonastaso DP, Romano G, Riccardi A, Nigra SG, Russo E, Angelini M, Agnoletti V, Guarino M, Cimmino CS, Spampinato MD, Francesconi R, Iaco F. Efficacy and safety of the serratus anterior plane block (SAP block) for pain management in patients with multiple rib fractures in the emergency department: a retrospective study. Eur J Trauma Emerg Surg. 2024 Dec;50(6):3177-3188. doi: 10.1007/s00068-024-02597-6. Epub 2024 Jul 17.

  PMID: 39020130 BACKGROUND

• Paul S, Bhoi SK, Sinha TP, Kumar G. Ultrasound-Guided Serratus Anterior Plane Block for Rib Fracture-Associated Pain Management in Emergency Department. J Emerg Trauma Shock. 2020 Jul-Sep;13(3):208-212. doi: 10.4103/JETS.JETS_155_19. Epub 2020 Sep 18.

  PMID: 33304071 BACKGROUND

• Hernandez N, de Haan J, Clendeninn D, Meyer DE, Ghebremichael S, Artime C, Williams G, Eltzschig H, Sen S. Impact of serratus plane block on pain scores and incentive spirometry volumes after chest trauma. Local Reg Anesth. 2019 Aug 2;12:59-66. doi: 10.2147/LRA.S207791. eCollection 2019.

  PMID: 31447581 BACKGROUND

• Kring RM, Mackenzie DC, Wilson CN, Rappold JF, Strout TD, Croft PE. Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. J Ultrasound Med. 2022 Nov;41(11):2695-2701. doi: 10.1002/jum.15953. Epub 2022 Feb 2.

  PMID: 35106815 BACKGROUND

• Kumar G, Kumar Bhoi S, Sinha TP, Paul S. Erector spinae plane block for multiple rib fracture done by an Emergency Physician: A case series. Australas J Ultrasound Med. 2020 Aug 30;24(1):58-62. doi: 10.1002/ajum.12225. eCollection 2021 Feb.

  PMID: 34760612 BACKGROUND

• Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

  PMID: 23923989 BACKGROUND

• Picard J, Meek T. Complications of regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:105-15. doi: 10.1111/j.1365-2044.2009.06205.x.

  PMID: 20377552 BACKGROUND

• Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.

  PMID: 16269301 BACKGROUND

• Sadauskas V, Fofana M, Brunson D, Choi J, Spain D, Quinn JV, Duanmu Y. Serratus anterior plane block improves pain and incentive spirometry volumes in trauma patients with multiple rib fractures: a prospective cohort study. Trauma Surg Acute Care Open. 2024 Jun 13;9(1):e001183. doi: 10.1136/tsaco-2023-001183. eCollection 2024.

  PMID: 38881827 BACKGROUND

• Choi J, Khan S, Hakes NA, Carlos G, Seltzer R, Jaramillo JD, Spain DA. Prospective study of short-term quality-of-life after traumatic rib fractures. J Trauma Acute Care Surg. 2021 Jan 1;90(1):73-78. doi: 10.1097/TA.0000000000002917.

  PMID: 32925583 BACKGROUND

• Choi J, Khan S, Sheira D, Hakes NA, Aboukhater L, Spain DA. Prospective study of long-term quality-of-life after rib fractures. Surgery. 2022 Jul;172(1):404-409. doi: 10.1016/j.surg.2021.11.026. Epub 2021 Dec 27.

  PMID: 34969527 BACKGROUND

• Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.

  PMID: 7996614 BACKGROUND

MeSH Terms

Conditions

Agnosia; Rib Fractures

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• Michelle Montenegro, MD

  Albert Einstein College of Medicine, Jacobi medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariella Gartenberg, MD

CONTACT

2017871762; ariella.applebaum@gmail.com

Michelle Montenegro, MD

CONTACT

7189185800; michelle.a.montenegro@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 10 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)