Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED)
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Experimental (SAPB)
Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain.
Intervention: Bupivacaine (Drug)
Control
Patients randomized to the control arm receive usual pain control treatment in the emergency department.
Intervention: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen (Drug)
Outcomes
Primary Outcomes
Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups
Time Frame: 60 minutes
Change 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 Outcomes
- Adverse events(60 minutes)
- Sensory testing(60 minutes)
- Non-opioid medications given (yes/no)(20, 40, 60 minutes)
- Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups(20, 40, 60 minutes)
- Successful analgesia for block group(20, 40, 60 minutes)
- Difference in total morphine equivalents(1, 4, 12, and 24 hours)
Investigators
Andrew A Herring
Associate Research Director, Department of Emergency Medicine, Highland Hospital
Alameda Health System