Clinical trial NCT02295098: Comparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures
Official title: Comparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rib Fractures
Wounds and Injuries
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Pain assessment immediately before and after catheter placement
timeFrame: within an hour before and after catheter placement
Secondary outcomes:
measure: successful placement of randomized intervention (paracostal vs. epidural catheter)
timeFrame: Within 24 hours of recruitment
measure: Comparison of analgesic effect as measured by daily pain scores
timeFrame: Duration of admission up to 30 days
measure: Comparison of improvements in pulmonary function
timeFrame: Duration of admission up to 30 days as long as the patient remains in the ICU
measure: Comparison of improvements in maximum daily incentive spirometry
timeFrame: Duration of admission up to 30 days
measure: Comparison of improvements in forced vital capacity
timeFrame: Duration of admission up to 30 days as long as the patient remains in the ICU
measure: Comparison of improvements in peak expiratory flow
timeFrame: Duration of admission up to 30 days as long as the patient remains in the ICU
measure: Number of patients in each group with pulmonary complications
timeFrame: Duration of admission up to 30 days
measure: ICU length of stay
timeFrame: Duration of admission up to 30 days
measure: Hospital length of stay
timeFrame: Duration of admission up to 30 days
measure: 30-day Mortality
timeFrame: Duration of admission up to 30 days
measure: Comparison of daily requirement for narcotics and other additional pain medications.
timeFrame: Duration of admission up to 30 days
measure: Number of patients who had alterations in their care related to the studied interventions (paracostal vs. epidural catheters)
timeFrame: Duration of admission up to 30 days
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health Medical Center, Department of Surgery, University of Colorado, Denver
name: Nina E Glass, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simon BJ, Cushman J, Barraco R, Lane V, Luchette FA, Miglietta M, Roccaforte DJ, Spector R; EAST Practice Management Guidelines Work Group. Pain management guidelines for blunt thoracic trauma. J Trauma. 2005 Nov;59(5):1256-67. doi: 10.1097/01.ta.0000178063.77946.f5. No abstract available.
citation: Truitt MS, Mooty RC, Amos J, Lorenzo M, Mangram A, Dunn E. Out with the old, in with the new: a novel approach to treating pain associated with rib fractures. World J Surg. 2010 Oct;34(10):2359-62. doi: 10.1007/s00268-010-0651-9.
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citation: Dahlgren N, Tornebrandt K. Neurological complications after anaesthesia. A follow-up of 18,000 spinal and epidural anaesthetics performed over three years. Acta Anaesthesiol Scand. 1995 Oct;39(7):872-80. doi: 10.1111/j.1399-6576.1995.tb04190.x.
citation: Carrier FM, Turgeon AF, Nicole PC, Trepanier CA, Fergusson DA, Thauvette D, Lessard MR. Effect of epidural analgesia in patients with traumatic rib fractures: a systematic review and meta-analysis of randomized controlled trials. Can J Anaesth. 2009 Mar;56(3):230-42. doi: 10.1007/s12630-009-9052-7. Epub 2009 Feb 11.
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