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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAlbert Einstein College of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patients in traumatic arrest or hemodynamic instability

Patient expected to be discharged from the hospital within 24 hours

Prisoner

Pregnancy

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

220 Participants
are grouped into 2 trial groups
Group A: Serratus Anterior Plane Block (SAPB)
Group B: Non-SAPB

Trial outcomes

Primary outcomes

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.

Time frame
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).

Time frame
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.

Time frame
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.

Time frame
ED admission to hospital discharge, up until 90 days

Secondary outcomes

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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

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Albert Einstein College of Medicine

Lead sponsor

Jacobi Medical Center

Collaborator