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

Not Recruiting
18 years or above
All
Phase N/A
124 participants needed

Brief description of study

The purpose of this study is to compare 2 pain control treatments for people with 3 or moreb fractures.

Detailed description of study

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 aftergesia placement.
  • Compare complications that occur in patients who receive ESPB versus TEA.
  • Compare dermatome levels relative to catheter placement that achieve analgesia for TEAd ESPB.
  • Compare differences in deep vein thrombosis (DVT) prophylaxis and incidence between ESPBd 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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rib Fractures
  • Age: 18 years or above
  • Gender: All

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 whichdication 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 pressorupport)
  • Tattoo at sight of catheter placement

Updated on 16 Sep 2025. Study ID: 11414

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