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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rib Fractures, Wounds and Injuries

Intervention / Treatment
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* Other: Thoracic epidural catheter placement
* Other: Paracostal catheter placement


Participation Criteria
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Eligibility Criteria
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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: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thoracic epidural catheter<br>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. | Other: Thoracic epidural catheter placement<br>* 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.<br>|
| Active Comparator: Paracostal catheter<br>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. | Other: Paracostal catheter placement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment immediately before and after catheter placement | Pain scores are assessed by nursing on an hourly basis in the ICU | within an hour before and after catheter placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful placement of randomized intervention (paracostal vs. epidural catheter) |  | Within 24 hours of recruitment | 
| Comparison of analgesic effect as measured by daily pain scores | Daily pain scores are assessed by nursing hourly in the ICU and every shift after transfer to the floor. These are measured by the Critical-Care Pain Observation Tool (CPOT). | Duration of admission up to 30 days | 
| Comparison of improvements in pulmonary function | Respiratory therapist assessment of pulmonary function (including incentive spirometry maximum, forced vital capacity, peak expiratory flow, respiratory rate and supplemental oxygen requirement) every shift will be reviewed for evidence of respiratory embarrassment. | Duration of admission up to 30 days as long as the patient remains in the ICU | 
| Comparison of improvements in maximum daily incentive spirometry | Nursing assessment of incentive spirometry every shift will be reviewed for evidence of respiratory embarrassment. | Duration of admission up to 30 days | 
| Comparison of improvements in forced vital capacity | Respiratory therapist assessment of forced vital capacity every shift will be reviewed for evidence of respiratory embarrassment. | Duration of admission up to 30 days as long as the patient remains in the ICU | 
| Comparison of improvements in peak expiratory flow | Respiratory therapist assessment of peak expiratory flow every shift will be reviewed for evidence of respiratory embarrassment. | Duration of admission up to 30 days as long as the patient remains in the ICU | 
| Number of patients in each group with pulmonary complications | All patients will be assessed daily for other evidence of respiratory embarrassment including: hypoxemia, pneumonia, empyema, need for mechanical ventilation, or readmission due to pulmonary complaints. | Duration of admission up to 30 days | 
| ICU length of stay |  | Duration of admission up to 30 days | 
| Hospital length of stay |  | Duration of admission up to 30 days | 
| 30-day Mortality |  | Duration of admission up to 30 days | 
| Comparison of daily requirement for narcotics and other additional pain medications. |  | Duration of admission up to 30 days | 
| Number of patients who had alterations in their care related to the studied interventions (paracostal vs. epidural catheters) | We will assess any possible alterations in care related to interventions (e.g., failure to mobilize, anticoagulate, etc.). | Duration of admission up to 30 days |