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

Indiana University

Status: Withdrawn

Conditions: Rib Fractures

Treatments: Procedure: TEA; Procedure: ESPB

Study type: Interventional

Funder types: Other

Identifiers

NCT05069961

11414

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

ESPB Group

Active Comparator group

Description:

20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump.

Treatment:

Procedure: ESPB

TEA Group

Active Comparator group

Description:

5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump.

Treatment:

Procedure: TEA