Comparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures

Completed · Not applicable

Conditions studied: Rib Fractures, Wounds and Injuries

In brief

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.

Key facts

Study ID

NCT02295098

Run by

University of Colorado, Denver

People needed

36

Starts

2015-08-19

Expected to finish

2017-06-01

Last updated by the study team

2018-06-08

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >/= 3 rib fractures on a single side
• Admitted to the Surgical ICU
• Recruited within 24 hours of admission

You may not qualify if…

• 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:
• 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)
• 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)
• History of extensive back surgery at the level of desired epidural placement
• Severe aortic stenosis, mitral stenosis, or pulmonary hypertension
• Inability to correct coagulopathy (to International Normalized Ratio>1.5)
• 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)
• 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)
• Concern for elevated intracranial pressure (we imagine these patients will also be intubated)

Where it is running

• Denver Health Medical Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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