Clinical trial NCT03619785: US-guided SAPB for Rib Fractures in the ED
Official title: Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rib Fractures
Rib Fracture Multiple
Keywords: Nerve Block
Serratus Anterior Plane Block
Ultrasound
Emergency Department
Lead sponsor: Alameda Health System
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: University of California, Los Angeles
First posted: 2018-08-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups
timeFrame: 60 minutes
Secondary outcomes:
measure: Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups
timeFrame: 20, 40, 60 minutes
measure: Difference in total morphine equivalents
timeFrame: 1, 4, 12, and 24 hours
measure: Successful analgesia for block group
timeFrame: 20, 40, 60 minutes
measure: Non-opioid medications given (yes/no)
timeFrame: 20, 40, 60 minutes
measure: Adverse events
timeFrame: 60 minutes
measure: Sensory testing
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Alameda Health System - Highland Hospital
state: California
Study officials:
affiliation: Alameda Health System - Highland Hospital
name: Andrew Herring, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alameda Health System - Highland Hospital
name: Josh Luftig, PA
role: PRINCIPAL_INVESTIGATOR
affiliation: Alameda Health System - Highland Hospital
name: Eben Clattenburg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alameda Health System - Highland Hospital
name: Daniel Mantuani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Alameda Health System - Highland Hospital
name: Arun Nagdev, MD
role: PRINCIPAL_INVESTIGATOR
References: