Denver, Colorado 80204


Purpose:

The investigators plan to compare the incidence of successful placement of epidural pain catheters versus paracostal catheters for the control of pain and prevention of pulmonary complications for adult trauma patients with blunt chest wall trauma resulting in multiple rib fractures. When a trauma patient has > or = to 3 rib fractures on the same side, is being admitted to the Surgical ICU, and is encountered within 72 hours from the time of their injury, they will be eligible for the study. If they (or a proxy) choose to participate, consent will be obtained and they will randomly be assigned to receive either an epidural or paracostal catheter for pain control. The aim of the study is to determine if paracostal catheters are noninferior to epidurals for controlling pain in multisystem trauma patients. Secondarily the investigators will evaluate success and time of placement of the assigned intervention and follow the patient throughout their hospital course to compare the success of analgesia provided by each modality along with any complications and/or benefits of the two types of catheters.


Criteria:

Inclusion Criteria: - >/= 3 rib fractures on a single side - Admitted to the Surgical ICU - Recruited within 24 hours of admission Exclusion Criteria: - Patient allergy to local anesthetics - Patient refusal - Inability to consent for any reason - Prisoners - Age < 18 - Pregnant women (pregnancy screen performed as part of routine trauma admission labs) - Absolute contraindications for either thoracic epidural or paracostal pain catheter placement which include: 1. Localized rash or skin infection over the likely site of insertion (We never want to translocate infectious material from the skin to the epidural space or even into the soft tissue where paracostal catheters lay, although for these there is more flexibility in adjusting placement) 2. Spinal/vertebral instability/fracture including any significant vertebral body injury and 3 or more spinous process fractures near the level of desired epidural placement (transverse process fractures are not considered a contraindication) 3. History of extensive back surgery at the level of desired epidural placement 4. Severe aortic stenosis, mitral stenosis, or pulmonary hypertension 5. Inability to correct coagulopathy (to International Normalized Ratio>1.5) 6. Persistent hemodynamic instability (hypotension with Systolic Blood Pressure<90 that does not respond to initial fluid boluses and requires ongoing pressors beyond the 72 hour window for enrollment) 7. Inability to cooperate and participate in placement (if intubated and sedated, for example) or to lie in the correct position for placement (lateral decubitus for paracostal pain catheters, either sitting up or lateral decubitus for epidural placement) 8. Concern for elevated intracranial pressure (we imagine these patients will also be intubated)


NCT ID:

NCT02295098


Primary Contact:

Principal Investigator
Nina E Glass, MD
Denver Health Medical Center, Department of Surgery, University of Colorado, Denver

Nina E Glass, MD
Phone: 303-602-1830
Email: nina.glass@ucdenver.edu


Backup Contact:

Email: fredric.pieracci@dhha.org
Fredric Pieracci, MD, MPH
Phone: 303-602-1830


Location Contact:

Denver, Colorado 80204
United States

Nina E Glass, MD
Phone: 720-441-3999
Email: nina.glass@ucdenver.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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