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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: University of Colorado, Denver

Current Primary Outcome: Pain assessment immediately before and after catheter placement [ Time Frame: within an hour before and after catheter placement ]

Original Primary Outcome: Primary outcome: successful placement of randomized intervention (paracostal vs. epidural catheter) [ Time Frame: Within 24 hours of recruitment ]

Current Secondary Outcome:

• successful placement of randomized intervention (paracostal vs. epidural catheter) [ Time Frame: 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).
• 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.
• 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.
• 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.
• 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.
• 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.
• ICU length of stay [ Time Frame: Duration of admission up to 30 days ]
• Hospital length of stay [ Time Frame: Duration of admission up to 30 days ]
• 30-day Mortality [ Time Frame: 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 ]
• 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.).

Original Secondary Outcome:

• 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).
• Comparison of improvements in pulmonary function [ Time Frame: Duration of admission up to 30 days ]
  Nursing 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 [ Time Frame: 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 [ Time Frame: Duration of admission up to 30 days ]
  Nursing assessment of forced vital capacity every shift will be reviewed for evidence of respiratory embarrassment.
• Comparison of improvements in peak expiratory flow [ Time Frame: Duration of admission up to 30 days ]
  Nursing assessment of peak expiratory flow every shift will be reviewed for evidence of respiratory embarrassment.
• 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.
• ICU length of stay [ Time Frame: Duration of admission up to 30 days ]
• Hospital length of stay [ Time Frame: Duration of admission up to 30 days ]
• 30-day Mortality [ Time Frame: 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 ]
• 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.).

Information By: University of Colorado, Denver

Dates:
Date Received: November 9, 2014
Date Started: August 2015
Date Completion: June 2017
Last Updated: December 5, 2016
Last Verified: December 2016