ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Aggressive Pain Management is Associated With Improved Outcomes in Blunt Thoracic Trauma (Thoracic)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01327287
Recruitment Status : Terminated (inability to recruit participants despite numerous attempts)
First Posted : April 1, 2011
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is designed to analyze the use of early aggressive pain management with thoracic epidural in eligible patients with blunt thoracic trauma.

Condition or disease
Thoracic Injury Rib Fracture Sternal Fracture

Detailed Description:

Due the limited availability of patient population this study requires together with the inclusion and exclusion criteria the study demands, this study will employ both a retrospective chart review process as well as prospective enrollment of qualified patients who provide consent to participate.

The two main groups being evaluated are: (1) eligible patients who received thoracic epidural within 48 hours of injury and (2) eligible patients who did not receive thoracic epidural within 48 hours of injury. In both retrospective and prospective approaches, the investigators will identify patients with blunt thoracic trauma who were eligible for thoracic epidural placement and received the treatment as well as those patients who were eligible but did not receive it. Hospital data such as ventilator days, ICU days, hospital days, hospital charges, and complications, etc. will be recorded.

A retrospective chart review of patients admitted to SFGH suffering from a blunt thoracic injury resulting in 3 or more rib fractures during a 5year time period from January 1, 2004 through January 1, 2009 will be conducted. Patient charts will be reviewed for pain management used for blunt thoracic trauma, hospital course, vitals, labs, and outcome measures. Similar to the prospective enrollment process, the retrospective chart review will screen for patients who had met the inclusion criteria and had not met any exclusion criteria.

Prospective patients admitted to SFGH suffering blunt thoracic injury (rib fractures, sternal fractures) requiring IV opioids for pain relief who do not fit exclusion criteria will be enrolled. Patients will be asked to give informed signed consent for the study doctor to place a thoracic epidural within 48 hours of injury and continued for a maximum of 5 days. The consent process will be twofold. For those who have consented to receive thoracic epidural and agreed to have their health information (HIPAA form) used for the study no additional permission will be required. However, for those patients who do not wish to receive epidural, consent will still be sought if their health information can be used to analyze that arm of the study that did not receive thoracic epidural.

Patient data such as vitals, labs and outcome measures will be recorded and analyzed. The data gathered both in the retrospective and prospective analyses will be used to assess utilization rate of thoracic epidural, and to determine if the use of thoracic epidural is associated with lower resource utilization and is cost effective. In both the retrospective chart review and prospective enrollment process, subjective pain, improved pulmonary function, amount of analgesia and overall clinical outcomes will be measured to determine if patients who received epidural catheters have significantly improved clinical outcomes than those patients who did not receive epidural catheter.


Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Early Aggressive Pain Management is Associated With Improved Outcomes in Blunt Thoracic Trauma
Study Start Date : February 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Trauma patients eligible to receive thoracic epidural
Patients admitted to the hospital suffering from blunt thoracic injury and who meet inclusion/exclusion criteria and receive thoracic epidural for pain
Control Arm
Trauma patients eligible to receive thoracic epidural but did not receive thoracic epidural for pain


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Hospital Length of stay [ Time Frame: An average of 8 weeks ]
    the hospital length of stay will be assessed for patients who received thoracic epidural compared to those who did not receive thoracic epidural.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients > 18 years of age admitted to San Francisco General Hospital Trauma service with blunt thoracic trauma requiring IV opioids for pain relief
Criteria

Inclusion Criteria:

  • > 18 years of age
  • Patients admitted to SFGH trauma service with blunt thoracic trauma (i.e. rib fractures, sternal fractures) requiring IV opioids for pain relief.

Exclusion Criteria:

  • Acute spine fractures or pre-existing spine deformity
  • Traumatic brain injury or spinal cord injury or altered mental status
  • Unstable pelvic fracture or open abdomen
  • Hemodynamic instability or major aortic injury (dissection, pseudoaneurysm)
  • Coagulopathy
  • Mechanical intubation
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327287


Locations
United States, California
University of California, San Francisco at San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01327287     History of Changes
Other Study ID Numbers: H9025-35075-01
10-04955 ( Other Identifier: UCSF CHR )
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by University of California, San Francisco:
thoracic epidural
blunt
blunt thoracic injury

Additional relevant MeSH terms:
Fractures, Bone
Rib Fractures
Thoracic Injuries
Wounds and Injuries