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

Not Applicable

Completed

• Conditions: Wounds and Injuries; Rib Fractures
• Interventions: Other: Paracostal catheter placement; Other: Thoracic epidural catheter placement

• Registration Number: NCT02295098
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-09
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-20
• Study Start: 2015-08-19
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracostal catheter	Paracostal catheter placement	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.
Thoracic epidural catheter	Thoracic epidural catheter placement	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.

Primary Outcome Measures

Name	Time	Method
Pain assessment immediately before and after catheter placement	within an hour before and after catheter placement	Pain scores are assessed by nursing on an hourly basis in the ICU

Secondary Outcome Measures

Name	Time	Method
Comparison of improvements in pulmonary function	Duration of admission up to 30 days as long as the patient remains in the ICU	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.
Comparison of improvements in maximum daily incentive spirometry	Duration of admission up to 30 days	Nursing assessment of incentive spirometry every shift will be reviewed for evidence of respiratory embarrassment.
Comparison of improvements in forced vital capacity	Duration of admission up to 30 days as long as the patient remains in the ICU	Respiratory therapist assessment of forced vital capacity every shift will be reviewed for evidence of respiratory embarrassment.
Comparison of improvements in peak expiratory flow	Duration of admission up to 30 days as long as the patient remains in the ICU	Respiratory therapist assessment of peak expiratory flow every shift will be reviewed for evidence of respiratory embarrassment.
successful placement of randomized intervention (paracostal vs. epidural catheter)	Within 24 hours of recruitment
Comparison of analgesic effect as measured by daily pain scores	Duration of admission up to 30 days	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).
Number of patients in each group with pulmonary complications	Duration of admission up to 30 days	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.
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)	Duration of admission up to 30 days	We will assess any possible alterations in care related to interventions (e.g., failure to mobilize, anticoagulate, etc.).

Trial Locations

Locations (1)

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States