Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures

Study Overview
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Brief Summary
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The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.

Detailed Description
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2.1 Primary Objective Compare efficacy of ESPB to TEA for MRF analgesia. 2.2 Secondary Objective Compare systemic opioid and non-opioid medication use in patients with ESPB and TEA. 2.3 Tertiary/Exploratory/Correlative Objectives Determine improvement in respiratory function in ESPB versus TEA before and after analgesia placement. Compare complications that occur in patients who receive ESPB versus TEA. Compare dermatome levels relative to catheter placement that achieve analgesia for TEA and ESPB. Compare differences in deep vein thrombosis (DVT) prophylaxis and incidence between ESPB and TEA. Differences in length of stay (LOS) for TEA versus ESPB. Differences in risk of delirium between TEA and ESPB. Differences in oxygen and ventilatory support between TEA and ESPB. Patient satisfaction of pain management.

Official Title
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Non- Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural Analgesia in Multimodal Pain Management of Multiple Rib Fractures

Conditions
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Rib Fractures

Intervention / Treatment
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* Procedure: ESPB
* Procedure: TEA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Radiological evidence of 3 or more rib fractures Within 48 hours of admission to hospital with rib fractures Can actively participate by answering questions during TEA or ESPB placement Moderate-severe (4-10 out of 10) pain at the time of enrollment Exclusion Criteria: Greater than 48 hrs since admission to the hospital with rib fractures Patient refusal Prisoner Infection at the site of TEA or ESPB insertion Allergy to local anesthetics Depth from skin to catheter placement target 6 or more centimeters Greater than 7 consecutive ribs involved on each side Other regional or epidural block already received Unable to follow commands/altered mental status Dementia Sepsis (temperature > 38 degrees Celsius & positive blood cultures) Elevated intracranial pressure (ICP > 12 mm Hg) Coagulopathy (INR > 1.4) or recent therapeutic anticoagulant use (varies with which medication the patient is on) Preexisting central nervous system disorders, such as multiple sclerosis Thrombocytopenia (Platelets <70,000) Spine fracture or previous back surgery Preload dependent states (aortic stenosis, hypertrophic obstructive cardiomyopathy) Aortic transection Hemodynamic instability (patients with MAPs <60 and/or patients requiring pressor support) Tattoo at sight of catheter placement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESPB Group<br>20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump. | Procedure: ESPB<br>* Ropivacaine is injected near the nerves in the back<br>|
| Active Comparator: TEA Group<br>5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump. | Procedure: TEA<br>* Bupivacaine is injected into the space around the spinal cord.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs. | Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain. | 24 hours after catheter placement | 
| MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs. | Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain. | 72 hours after catheter placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine total systemic opioid and non-opioid medication use in patients with ESPB and TEA by reviewing patient EMR. | Normalize medication use by subtracting baseline opioid and non-opioid medication use for amount received while hospitalized and compare injury severity prior to analysis. | After patient discharge up to 7 days |