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Pain ManagementSAPBNCT07032766

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

An observational study of Pain Management and Rib Fracture Multiple, run by Albert Einstein College of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Type of treatment
Injection or infusion
How many people
220 participants
Where
1 siteUnited States
Study dates
10 Aug 2025to Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ariella Gartenberg, MD contact

2017871762

ariella.applebaum@gmail.com

Michelle Montenegro, MD contact

7189185800

michelle.a.montenegro@gmail.com

United States1 site, 1 recruiting
  • Jacobi Medical Center

    The Bronx, New York, 10461

    Ariella Gartenberg, MD, 201-787-1762, ariella.applebaum@gmail.com

    Michelle Montenegro, MD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Rib fractures are a common complication of blunt thoracic trauma, reported in 10% of all injured trauma patients. They are associated with significant long-term disability, decreased quality of life, and increased patient morbidity and mortality. Pain from multiple rib fractures can result in reduced respiratory effort, atelectasis, inability to clear secretions, and a reduction in vital capacity. This, in turn, can result in hypoxemia, pneumonia, and acute respiratory failure. Adequate and early pain management is therefore crucial to provide symptomatic relief, decrease splinting, and prevent secondary respiratory complications.

While systemic analgesia, notably opioids, are frequently used in the emergency department (ED) for pain control, they are associated with poor side effect profiles. Opioids place patients at risk for delirium, chronic addiction, respiratory depression, and constipation. Traditional regional anesthesia techniques, including paravertebral, intercostal and epidural injections, are resource-intensive, time consuming, limited in dermatomal distribution and associated with significant potential complications (diaphragmatic complications, local anesthetic toxicity, vasovagal syncope, pneumothoraces). Such techniques are not feasible in the ED. Ultrasound-guided fascial plane blocks have thus emerged as an alternative tool for proper pain control in patients with rib fractures in the ED. Fascial plane blocks include the serratus anterior plane block (SAPB) and the erector spinae plane block (ESPB).

The SAPB has demonstrated efficacy in providing safe analgesia for anterolateral rib fractures, while the ESPB has demonstrated efficacy in pain relief of posterior rib fractures. A benefit of SAPB is that it can be performed in the supine position, in contrast to other regional anesthesia techniques. The SAPB utilizes a linear transducer to identify the serratus anterior muscle and instill local anesthetic into the fascial plane overlying the muscle. The anesthetic targets the lateral cutaneous branches of the intercostal nerves, with a wide distribution centered around T3-T8. The anesthetic may also block the long thoracic and thoracodorsal nerve if injected superficial to the serratus anterior muscle. Recent studies have demonstrated improvement in chest wall pain scores and incentive spirometry (IS) following SAPB in adult patients with rib fractures. No SAPB attributed complications have been reported, likely related to the clear landmarks of the procedure and injection of anesthetic into a compartment distant from major vasculature. To date, no studies have investigated the effects of SAPB on morbidity and mortality as compared to standard oral or intravenous (IV) analgesics in patients with multiple rib fractures. The authors aim to prospectively assess whether SAPB for multiple anterolateral rib fractures demonstrates reduction in key outcome measures as compared to standard analgesic regimens. The study is a prospective cohort study which will take place at a single urban level 1 trauma center.

For patients who meet inclusion and exclusion criteria, SAPB will be utilized as part of a multimodal analgesia strategy if an emergency physician trained in the procedure is present in the ED within 24 hours of injury. If a SAPB-trained emergency physician is not available, the patient will be placed in the non-SAPB group. Patients will be enrolled in the study by clinicians participating in their care who are involved in performance of the SAPB. Morbidity and mortality, the composite outcome measures, will be assessed through various primary outcome measures, each indexed separately (see Outcome Measures section).

Keywords
serratus anterior plane block, rib fractures, mortality, morbidity
Medical subject headings
Agnosia, Rib Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07032766
Study groupRoleWhat they receive
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-SAPBPatients in this arm will receive IV analgesia, mainly opioid therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

    Measured: ED arrival to hospital discharge, up until 90 days

  3. 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.

    Measured: ED admission to discharge , up until 90 days

  4. 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.

    Measured: ED admission to hospital discharge, up until 90 days

  5. 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.

    Measured: ED admission until hospital discharge, up until 90 days

Secondary outcomes (2)
  1. Pain Intensity

    Patient-reported pain scores will be recorded using an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain) such that higher scores are associated with increased pain intensity. Pain scores will be recorded upon initial evaluation (baseline) and 30 and 60 minutes following SAPB. Scores will be summarized by study arm/group using basic descriptive statistics.

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

  2. Number of patients per group that required additional analgesia

    The number of patients that required additional opioid analgesia after the administration of IV opioid medications or initial (SAPB) block will be assessed and summarized by study arm/group using basic descriptive statistics.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study start10 Aug 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07032766
Sponsor's protocol ID
2024-16493
Acronym
SAPB
Status last verified
Aug 2026
First submitted
13 Jun 2025
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study protocol, Statistical Analysis Plan (SAP), and Informed Consent Form (ICF) will be shared.

Publications

  • 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.

    PubMed 32064417
  • 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.

    PubMed 33511786
  • 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.

    PubMed 39020130
  • 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.

    PubMed 33304071
  • 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.

    PubMed 31447581
  • 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.

    PubMed 35106815
  • 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.

    PubMed 34760612
  • 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.

    PubMed 23923989
  • 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.

    PubMed 20377552
  • 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.

    PubMed 16269301
  • 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.

    PubMed 38881827
  • 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.

    PubMed 32925583
  • 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.

    PubMed 34969527
  • 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.

    PubMed 7996614

Questions about this trial

What is this clinical trial studying?

An observational study of Pain Management and Rib Fracture Multiple, run by Albert Einstein College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ariella Gartenberg, MD (2017871762, ariella.applebaum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07032766, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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