NCT01327287

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

March 29, 2011

Last Update Submit

April 16, 2015

Conditions

Keywords

thoracic epiduralbluntblunt thoracic injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    An average of 8 weeks

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \> 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco at San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Thoracic InjuriesRib Fractures

Condition Hierarchy (Ancestors)

Wounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2011

First Posted

April 1, 2011

Study Start

February 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations