Clinical Trial: Optimal Method of Pain Management in Patients With Multiple Rib Fractures

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures

Brief Summary:

Rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are used to treat the pain, but placement can be risky as rib fractures are often associated with other injuries and complications.

An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved device that automatically and continuously delivers medication to the region of the thoracic intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system effectively reduced pain and increased lung volumes after one hour, in patients with three or more rib fractures. However, that study sample was small and did not have a comparison group. In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We hypothesize that trauma patients with three or more rib fractures, who receive pain management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus have a shorter hospital length of stay (LOS) when compared with epidural analgesia.


Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Hospital length of stay/time to achieve discharge criteria [ Time Frame: Patient will be followed for the duration of hospital stay, 1 week ]

The study will compare the time to achieve discharge criteria between the two groups. Readiness for discharge is defined by the following criteria:

  1. Visual Analog Score (VAS) for pain below 4 (of a maximum 10);
  2. Ability to perform incentive spirometry with sustained maximal inspiration for three seconds;
  3. Hemodynamic stability (heart rate <100 beats/min, respiratory rate <20 breaths/min, and systolic blood pressure >90mmHg at 3 consecutive time points that are 10 minutes apart) and oxygen saturation greater than 95% on room air;
  4. Absence of neurological deficits; and
  5. Monitored for at least 1 hour after ON Q® catheter placement to ensure no immediate complications from placement or local anesthestic toxicity.


Original Primary Outcome: Hospital length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]

Current Secondary Outcome: Pain score reduction [ Time Frame: Patient will be followed for duration of hospital stay and through daily phone calls upon discharge ]

Decrease in pain as measured by the Visual Analog Scale (VAS) pre-placement and 60 min post-placement of intervention. Pain score will be followed for the duration of the intervention.


Original Secondary Outcome: Pain reduction [ Time Frame: Participants will be evaluated twice daily (9am and 6pm) for the duration of their hospital stay, averaging 1 week. ]

Decrease in pain as measured by the Visual Analog Scale (VAS) pre-placement and 60 min post-placement of intervention followed by twice daily (9AM and 6PM) for the duration of their hospital stay.


Information By: Massachusetts General Hospital

Dates:
Date Received: July 21, 2011
Date Started: October 2012
Date Completion: October 2014
Last Updated: October 28, 2013
Last Verified: October 2013