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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Rib Fractures; Wounds and Injuries

Treatments: Other: Paracostal catheter placement; Other: Thoracic epidural catheter placement

Study type: Interventional

Funder types: Other

Identifiers

NCT02295098

14-1979

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Thoracic epidural catheter

Active Comparator group

Description:

Thoracic epidurals work by delivering local anesthetics and narcotics to the epidural space, which then diffuse into the spinal nerve roots and block the transmission of pain from the chest wall to the spinal cord and brain.

Treatment:

Other: Thoracic epidural catheter placement

Paracostal catheter

Active Comparator group

Description:

Paracostal catheters run along the outer surface of the chest wall and act by delivering local anesthetics to the intercostal nerves as traverse the lower border of the ribs.

Treatment:

Other: Paracostal catheter placement