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| Name | Class |
|---|---|
| I-Flow | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral catheter (ON-Q® Pain Relief System) | Experimental |
| |
| Thoracic epidural catheter | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ON-Q® Pain Relief System | Procedure | Identify insertion site lateral to paraspinous muscles and posteromedial to the rib fractures. Then, incise skin and soft tissue down to the level of the rib. Advance tunneler perpendicular to chest wall until it contacts the rib, then, advance superiorly at 45° angle in the extrathoracic space. Remove tunneler and advance catheter in space created. Attach catheter to pump filled with 0.2% ropivacaine at infusion rate of 2-12ml/hr. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay/time to achieve discharge criteria | The study will compare the time to achieve discharge criteria between the two groups. Readiness for discharge is defined by the following criteria:
| Patient will be followed for the duration of hospital stay, 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score reduction | 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. | Patient will be followed for duration of hospital stay and through daily phone calls upon discharge |
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Inclusion criteria:
Age ≥ 18 years;
Three or more rib fractures;
Pain
Patient has capacity to provide informed consent, as determined by:
Exclusion criteria:
All women of child-bearing age will receive a urine pregnancy test prior to the start of the interventional portion of the study. A positive test result excludes the patient from inclusion in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katharine M Koury, BA | Contact | 617-643-7095 | kkoury@partners.org | |
| Leily Naraghi, MD | Contact | 617-480-1668 | lnaraghi@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| George C Velmahos, Md, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20567973 | Background | Truitt MS, Mooty RC, Amos J, Lorenzo M, Mangram A, Dunn E. Out with the old, in with the new: a novel approach to treating pain associated with rib fractures. World J Surg. 2010 Oct;34(10):2359-62. doi: 10.1007/s00268-010-0651-9. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Thoracic epidural catheter | Procedure | Introduce needle into the interspinous space of the vertebral column and advance into the epidural space. Advance the epidural catheter about 3-5 cm into the epidural space and remove the needle. |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |