Skip to content

US-guided SAPB for Rib Fractures in the ED

Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED)

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03619785
Enrollment
70
Registered
2018-08-08
Start date
2018-11-06
Completion date
2019-08-31
Last updated
2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rib Fracture Multiple, Rib Fractures

Keywords

Nerve Block, Serratus Anterior Plane Block, Ultrasound, Emergency Department

Brief summary

The purpose of this randomized controlled study is to determine whether the serratus anterior plane block reduces pain more than the usual treatment for rib fractures in the same amount of time.

Detailed description

Patients with unilateral rib fractures in the Highland Hospital Emergency Department who agree to participate will be randomized 1:1 to either the control group or the experimental group. Those in the control group will receive the usual oral and/or IV pain medication as needed. The experimental group will receive an ultrasound-guided serratus anterior plane block. Numerical pain rating scale scores at rest and when taking a deep breath will be recorded pre-intervention and at times 0, 20, 40, and 60. At time 60, patients who received the SAPB will receive sensory testing. Patients will be offered additional pain medication as needed at times 20, 40, and 60.

Interventions

DRUGBupivacaine

Patient will be positioned supine or in the lateral decubitus position on the side contralateral to the fracture(s). A 3.5 in 20-gauge needle, extension tubing, and a 30 mL syringe loaded with 0.25% bupivacaine and 3 mL of 1% lidocaine loaded in a 5 mL syringe with a 27-gauge needle will be prepared. The ribs, teres minor, latissimus dorsi, and serratus anterior will be identified with bedside US and the site of entry marked along the lateral aspect of the 4th-5th rib. The skin will be sterilized and lidocaine placed at the site of entry. The needle will be introduced at a steep angle and advanced in-plane, under US-guidance, to the plane superficial to the serratus anterior muscle. A test dose of normal saline will confirm proper needle tip placement with opening of the intramuscular layer. Injection with aliquots of 3-5 mL after negative aspiration will continue until 30mL of 0.25% bupivacaine are administered.

DRUGFentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen

Oral or IV pain medication as needed.

Sponsors

Oregon Health and Science University
CollaboratorOTHER
University of California, Los Angeles
CollaboratorOTHER
Andrew A Herring
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy. * Written informed consent must be obtained from each patient prior to entering the study. * Patients with moderate to severe pain (NRS 4 to 10) as a result of one or more rib fractures occurring at levels T2-T8, measured on a self-reported NRS.

Exclusion criteria

* Patient refusal * Patients with significant pain from other injuries (as determined at the discretion of the treating physician) * Patients deemed critically ill by provider * Patients with decompensated psychiatric disorders * Pregnant patients (positive urine or serum B-HCG) * History of heart block or bradycardia * History of uncontrolled seizures * Patients allergic to lidocaine, bupivacaine, ropivacaine, or morphine * Patients with bilateral rib fractures

Design outcomes

Primary

MeasureTime frameDescription
Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups60 minutesChange in Numeric Pain Rating Scale scores between time 0 and time 60 between block and control groups: Numeric Pain Rating Scale score at 0 minutes minus Numeric Pain Rating Scale score at 60 minutes, where a score of 0 is no pain and 10 is the worst pain the patient can imagine.

Secondary

MeasureTime frameDescription
Adverse events60 minutesProportion of patients with new onset of seizure, arrhythmias, hyper or hypotension (SBP\<90 or \>180), hypoxia, nausea, lightheadedness, vomiting.
Difference in total morphine equivalents1, 4, 12, and 24 hoursDifference in total parenteral morphine equivalents received during study period (0 minutes to 60 minutes) and at 4, 12, and 24 hours (unless discharged from the hospital prior to 24 hours) in the block and control groups.
Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups20, 40, 60 minutesChange in Numeric Pain Rating Scale score for resting chest pain and dynamic chest pain at 20, 40, and 60 minutes between block and control groups, where a score of 0 is no pain and 10 is the worst pain the patient can imagine.
Non-opioid medications given (yes/no)20, 40, 60 minutesNSAID, APAP, Gabapentin administered in block versus control groups.
Sensory testing60 minutesSensory testing to cold stimulus (alcohol swab) in the block group along the lateral sternal, anterior axillary, and posterior axillary lines at the levels of T2-T10 using a 3-point scale: 0 (unchanged), 1 (reduced), or 2 (no sensation).
Successful analgesia for block group20, 40, 60 minutesSuccessful analgesia at 20, 40 and 60 minutes: Proportion of patients not receiving morphine dosing.

Countries

United States

Contacts

Primary ContactAndrew Herring
aherring@alamedahealthsystem.org510-633-7498
Backup ContactJennifer Sun
jennsun@alamedahealthsystem.org510-437-8364

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026