Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia

Conditions
-----------------
Rib Fractures

Intervention / Treatment
-----------------
* Drug: ESP block with bupivacaine
* Other: Saline control/sham injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: radiographic evidence of unilateral rib fracture(s). able to consent and actively participate in the study. moderate to severe pain (defined as numerical pain rating score >/ 4 ) at time of enrollment. Exclusion Criteria: known allergy or hypersensitivity to local anesthetics or morphine. infection at site of ESP block placement. depth over 5 cm from skin to transverse process visualized with ultrasound. additional injuries that preclude positioning for ESP block placement. severe traumatic brain or spinal cord injury. severe altered mental status, such that pain could not be assessed. extra thoracic injuries for which rib pain is reported as less than the rest of the injuries. adjunctive epidural catheter pain control. other regional anesthetic blocks. pregnancy or prisoner status. unstable vital signs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erector spinae plane block (ESP block) with bupivacaine<br>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. | Drug: ESP block with bupivacaine<br>* 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.<br>|
| Placebo Comparator: ESP block with saline/sham injection<br>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. | Other: Saline control/sham injection<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intravenous (IV) and oral narcotic analgesic use | narcotic use will be measured in morphine milligram equivalents (MME), based on dosing and frequency. | From enrollment/baseline in the study through the study period, up to 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | 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) | 24 hours post-baseline | 
| Hospital length of stay (LOS) | LOS will be identified through the electronic medical record. | 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. | 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. | 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. | From enrollment/baseline in the study through the study period, up to 24 hours. |