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

June 6, 2018 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Thoracic epidural catheter
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
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.
Active Comparator: Paracostal catheter
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Within 24 hours of recruitment
Within 24 hours of recruitment
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).
Duration of admission up to 30 days
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.
Duration of admission up to 30 days as long as the patient remains in the ICU
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.
Duration of admission up to 30 days
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.
Duration of admission up to 30 days as long as the patient remains in the ICU
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.
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
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.
Duration of admission up to 30 days
ICU length of stay
Time Frame: Duration of admission up to 30 days
Duration of admission up to 30 days
Hospital length of stay
Time Frame: Duration of admission up to 30 days
Duration of admission up to 30 days
30-day Mortality
Time Frame: Duration of admission up to 30 days
Duration of admission up to 30 days
Comparison of daily requirement for narcotics and other additional pain medications.
Time Frame: Duration of admission up to 30 days
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)
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.).
Duration of admission up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Nina E Glass, MD, Denver Health Medical Center, Department of Surgery, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

November 9, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

June 8, 2018

Last Update Submitted That Met QC Criteria

June 6, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1979

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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