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

Not yet recruiting

• Conditions: Pain Management; Rib Fracture Multiple; Serratus Anterior Plane Block

• Registration Number: NCT07032766
• Lead Sponsor: Albert Einstein College of Medicine

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.

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).

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-13
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

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
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients with Hospital Acquired Pneumonia (HAP) Events	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	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	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)	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	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.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity	Baseline (initial evaluation) and 30 and 60 minutes after SAPB is performed	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.
Number of patients per group that required additional analgesia	Up until 24 hours after the initial block or IV opioid medication administration	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.

Trial Locations

Locations (1)

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States