The study will be a prospective randomized double blinded placebo controlled clinical trial using ultrasound guided erector spinae plane block as an analgesic adjunct among adult emergency department (ED) patients with rib fractures using mean morphine milligram equivalents as the primary outcome.
Aim 1: Given the novelty of the erector spinae plane nerve block and limited data from anesthesia literature, aim 1 is to obtain preliminary data regarding quantity of mean morphine equivalents received by control and experimental groups for an initial subset of 50 patients to improve sample size calculation and better power the study. Aim 2: Evaluate efficacy of ED performed ultrasound guided ESP block in delivering analgesia by evaluating difference in morphine milligram equivalents (MME) as well as pain scores during ED stay and hospital admission between the experimental and control groups. Aim 3: Evaluate adverse event rates related to ultrasound guided ESP block placement as well as rates of rib-fracture related complications between control and experimental groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle.
Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle.
Total intravenous (IV) and oral narcotic analgesic use
narcotic use will be measured in morphine milligram equivalents (MME), based on dosing and frequency.
Time frame: From enrollment/baseline in the study through the study period, up to 24 hours.
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time frame: Baseline (immediately following recruitment).
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time frame: 30 minutes post-baseline
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time frame: 1 hour post-baseline
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time frame: 4 hours post-baseline
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
Time frame: 12 hours post-baseline
Pain score
Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
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Time frame: 24 hours post-baseline
Hospital length of stay (LOS)
LOS will be identified through the electronic medical record.
Time frame: From hospital admission to hospital discharge, up to 30 days.
Number of Patients Who Develop Pneumonia
Identified through review of the electronic medical record for a discharge diagnosis of pneumonia, or readmission diagnosis of pneumonia within 1 month from presentation.
Time frame: From admission to 30 days from admission.
Adverse events associated with the nerve block itself.
Adverse events will include: hypotension, respiratory depression, and nausea or vomiting. Hypotension will be defined as a systolic blood pressure \< 90 mmHg and respiratory depression as respiratory rate \< 10 breaths per minute. Nausea or vomiting will be defined as patient-reported sensation of nausea or actual emesis, documented emesis in the medical record, or administration of an antiemetic during the study period.
Time frame: Within two hours of administration of the nerve block.
Total non-narcotic analgesic use.
Non-narcotic analgesic use will be measured by medical record review of all non-narcotic medications. Groups will be compared with respect to each category: non-steroidal anti-inflammatory use, acetaminophen use, local anesthetic patch use.
Time frame: From enrollment/baseline in the study through the study period, up to 24 hours.