Clinical trial NCT05069961: Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures
Official title: Non- Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural Analgesia in Multimodal Pain Management of Multiple Rib Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rib Fractures
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 24 hours after catheter placement
measure: 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.
timeFrame: 72 hours after catheter placement
Secondary outcomes:
measure: Determine total systemic opioid and non-opioid medication use in patients with ESPB and TEA by reviewing patient EMR.
timeFrame: After patient discharge up to 7 days
Other outcomes:
measure: Incentive spirometry
timeFrame: Baseline, pre-intervention and immediately following intervention.
measure: Rate of adverse events/complications related to ESPB and TEA
timeFrame: Duration of hospital stay up to 7 days.
measure: Dermatome levels with analgesia
timeFrame: Immediately following infusion.
measure: Dermatome levels with analgesia
timeFrame: 30 minutes after infusion.
measure: Dermatome levels with analgesia
timeFrame: Once a day in the morning, after intervention. They will be checked until the catheter is removed, which will be 7 days at the longest.
measure: Risk assessment profile (RAP) score
timeFrame: After patient discharge up to 7 days
measure: The time spent in the intensive care unit (ICU)
timeFrame: Duration of hospital stay, up to 7 days.
measure: Total length of hospital stay
timeFrame: Up to 7 days.
measure: Confusion assessment method (CAM-ICU)
timeFrame: Daily during hospital stay up to 7 days.
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: Daily during hospital stay up to 7 days.
measure: FiO2 and time on a ventilator
timeFrame: Duration of hospital stay, up to 7 days.
measure: Participant satisfaction assessed on a 5 pt. scale
timeFrame: Daily during hospital stay, up to 7 days.
measure: Pain scores
timeFrame: Duration of hospital stay, up to 7 days.
Locations:
Study officials:
affiliation: Indiana University School of Medicine
name: Ross Mirman, MD
role: PRINCIPAL_INVESTIGATOR
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