Thoracic InjuryThoracicNCT01327287
Early Aggressive Pain Management is Associated With Improved Outcomes in Blunt Thoracic Trauma
An observational study of Thoracic Injury and Rib Fracture, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study is designed to analyze the use of early aggressive pain management with thoracic epidural in eligible patients with blunt thoracic trauma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thoracic Injury, Rib Fracture, Sternal Fracture
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- > 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco at San Francisco General Hospital
San Francisco, California, 94110
About this study
This study is designed to analyze the use of early aggressive pain management with thoracic epidural in eligible patients with blunt thoracic trauma.
Read the 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.
- Conditions
- Thoracic Injury, Rib Fracture, Sternal Fracture
- Keywords
- thoracic epidural, blunt, blunt thoracic injury
- Medical subject headings
- Thoracic Injuries, Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of stay
the hospital length of stay will be assessed for patients who received thoracic epidural compared to those who did not receive thoracic epidural.
Measured: An average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startFeb 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: inability to recruit participants despite numerous attempts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic InjuryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327287
- Sponsor's protocol ID
- H9025-35075-01
- Other IDs
- 10-04955
- Acronym
- Thoracic
- Status last verified
- Apr 2015
- First submitted
- 29 Mar 2011
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Aggressive Pain Management is Associated With Improved Outcomes in Blunt Thoracic Trauma
- ClinicalTrials.gov ID
- NCT01327287
- Acronym / sponsor ID
- Thoracic / H9025-35075-01
- Conditions
- Thoracic Injury, Rib Fracture, Sternal Fracture
- Keywords
- thoracic epidural, blunt, blunt thoracic injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inability to recruit participants despite numerous attempts
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to analyze the use of early aggressive pain management with thoracic epidural in eligible patients with blunt thoracic trauma.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- > 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: inability to recruit participants despite numerous attempts). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Injury and Rib Fracture, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inability to recruit participants despite numerous attempts). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of stay (time frame: An average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.