US-guided SAPB for Rib Fractures in the ED
- Conditions
- Rib FracturesRib Fracture Multiple
- Interventions
- Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen
- Registration Number
- NCT03619785
- Lead Sponsor
- Andrew A Herring
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen Patients randomized to the control arm receive usual pain control treatment in the emergency department. Experimental (SAPB) Bupivacaine Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain.
- Primary Outcome Measures
Name Time Method Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups 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 Outcome Measures
Name Time Method Adverse events 60 minutes Proportion of patients with new onset of seizure, arrhythmias, hyper or hypotension (SBP\<90 or \>180), hypoxia, nausea, lightheadedness, vomiting.
Sensory testing 60 minutes Sensory 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).
Non-opioid medications given (yes/no) 20, 40, 60 minutes NSAID, APAP, Gabapentin administered in block versus control groups.
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 Change 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.
Successful analgesia for block group 20, 40, 60 minutes Successful analgesia at 20, 40 and 60 minutes: Proportion of patients not receiving morphine dosing.
Difference in total morphine equivalents 1, 4, 12, and 24 hours Difference 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.
Trial Locations
- Locations (1)
Alameda Health System - Highland Hospital
🇺🇸Oakland, California, United States