Back to resultsComparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures
Primary Purpose
Rib Fractures, Wounds and Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thoracic epidural catheter placement
Paracostal catheter placement
Sponsored by
About this trial
This is an interventional treatment trial for Rib Fractures
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:
- 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)
Sites / Locations
- Denver Health Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Thoracic epidural catheter
Paracostal catheter
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Pain assessment immediately before and after catheter placement
Pain scores are assessed by nursing on an hourly basis in the ICU
Secondary Outcome Measures
successful placement of randomized intervention (paracostal vs. epidural catheter)
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).
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.
Comparison of improvements in maximum daily incentive spirometry
Nursing assessment of incentive spirometry every shift will be reviewed for evidence of respiratory embarrassment.
Comparison of improvements in forced vital capacity
Respiratory therapist assessment of forced vital capacity every shift will be reviewed for evidence of respiratory embarrassment.
Comparison of improvements in peak expiratory flow
Respiratory therapist assessment of peak expiratory flow every shift will be reviewed for evidence of respiratory embarrassment.
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.
ICU length of stay
Hospital length of stay
30-day Mortality
Comparison of daily requirement for narcotics and other additional pain medications.
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.).
Full Information
NCT ID
NCT02295098
First Posted
November 9, 2014
Last Updated
June 6, 2018
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT02295098
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 19, 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures, Wounds and Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thoracic epidural catheter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Paracostal catheter
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Thoracic epidural catheter placement
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Paracostal catheter placement
Intervention Description
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 Outcome Measure Information:
Title
Pain assessment immediately before and after catheter placement
Description
Pain scores are assessed by nursing on an hourly basis in the ICU
Time Frame
within an hour before and after catheter placement
Secondary Outcome Measure Information:
Title
successful placement of randomized intervention (paracostal vs. epidural catheter)
Time Frame
Within 24 hours of recruitment
Title
Comparison of analgesic effect as measured by daily pain scores
Description
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).
Time Frame
Duration of admission up to 30 days
Title
Comparison of improvements in pulmonary function
Description
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.
Time Frame
Duration of admission up to 30 days as long as the patient remains in the ICU
Title
Comparison of improvements in maximum daily incentive spirometry
Description
Nursing assessment of incentive spirometry every shift will be reviewed for evidence of respiratory embarrassment.
Time Frame
Duration of admission up to 30 days
Title
Comparison of improvements in forced vital capacity
Description
Respiratory therapist assessment of forced vital capacity every shift will be reviewed for evidence of respiratory embarrassment.
Time Frame
Duration of admission up to 30 days as long as the patient remains in the ICU
Title
Comparison of improvements in peak expiratory flow
Description
Respiratory therapist assessment of peak expiratory flow every shift will be reviewed for evidence of respiratory embarrassment.
Time Frame
Duration of admission up to 30 days as long as the patient remains in the ICU
Title
Number of patients in each group with pulmonary complications
Description
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.
Time Frame
Duration of admission up to 30 days
Title
ICU length of stay
Time Frame
Duration of admission up to 30 days
Title
Hospital length of stay
Time Frame
Duration of admission up to 30 days
Title
30-day Mortality
Time Frame
Duration of admission up to 30 days
Title
Comparison of daily requirement for narcotics and other additional pain medications.
Time Frame
Duration of admission up to 30 days
Title
Number of patients who had alterations in their care related to the studied interventions (paracostal vs. epidural catheters)
Description
We will assess any possible alterations in care related to interventions (e.g., failure to mobilize, anticoagulate, etc.).
Time Frame
Duration of admission up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina E Glass, MD
Organizational Affiliation
Denver Health Medical Center, Department of Surgery, University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16385313
Citation
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Comparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures
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