Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Managem… (NCT05069961) | Clinical Trial Compass
WithdrawnNot Applicable
Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures
Stopped: Study was closed with IRB as PI wants to design the protocol extensively.
0Started 2023-05-31
Plain-language summary
The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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
2
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.