Skip to main content
OpenTrials
Completed

NCT Number: NCT02295098

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rib Fractures Fractures, Bone Thoracic Injuries Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Thoracic epidural catheter placement

Other

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.

Paracostal catheter placement

Other

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.

Primary outcomes

  1. Pain assessment immediately before and after catheter placement

    Time frame: within an hour before and after catheter placement

    Pain scores are assessed by nursing on an hourly basis in the ICU

Secondary outcomes

  1. successful placement of randomized intervention (paracostal vs. epidural catheter)

    Time frame: Within 24 hours of recruitment

  2. Comparison of analgesic effect as measured by daily pain scores

    Time frame: 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).

  3. Comparison of improvements in pulmonary function

    Time frame: 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.

  4. Comparison of improvements in maximum daily incentive spirometry

    Time frame: Duration of admission up to 30 days

    Nursing assessment of incentive spirometry every shift will be reviewed for evidence of respiratory embarrassment.

  5. Comparison of improvements in forced vital capacity

    Time frame: 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.

  6. Comparison of improvements in peak expiratory flow

    Time frame: 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.

  7. Number of patients in each group with pulmonary complications

    Time frame: 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.

  8. ICU length of stay

    Time frame: Duration of admission up to 30 days

  9. Hospital length of stay

    Time frame: Duration of admission up to 30 days

  10. 30-day Mortality

    Time frame: Duration of admission up to 30 days

  11. Comparison of daily requirement for narcotics and other additional pain medications.

    Time frame: Duration of admission up to 30 days

  12. Number of patients who had alterations in their care related to the studied interventions (paracostal vs. epidural catheters)

    Time frame: 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.).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2014
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.