3 or More Rib Fractures Clinical Trial
Official title:
Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures
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.
| Status | Recruiting |
| Enrollment | 96 |
| Est. completion date | October 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: 1. Age = 18 years; 2. Three or more rib fractures; 3. Pain 1. Severe pain (i.e. causing deleterious affect on respiratory mechanics, respiratory rate, or oxygen saturations), OR 2. Mild to moderate pain (i.e. minimally affecting respiratory mechanics, respiratory rate, or oxygen saturations) that does not respond to oral or intravenous analgesics within 4 hours; 4. Patient has capacity to provide informed consent, as determined by: 1. Clinical assessment by study staff MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD; 2. GCS 15; 3. Clinical assessment by independent MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD. Exclusion criteria: 1. Lack capacity to provide informed consent; 2. Intubation at time of enrollment; 3. Contraindications to procedure (e.g. known allergy to local anesthetics). 4. Presence of infection at site of catheter placement; 5. Current use of anticoagulant medication; 6. Known allergy to silver; 7. Inability to obtain informed consent; 8. Body weight > 300 lbs; 9. Pregnancy; 10. Significant co-morbid medical illness that might alter the metabolism of the anesthetic agents and result in unexpected toxicity (hepatic, renal or cardiopulmonary disease). 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts General Hospital | I-Flow |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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: Visual Analog Score (VAS) for pain below 4 (of a maximum 10); Ability to perform incentive spirometry with sustained maximal inspiration for three seconds; 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; Absence of neurological deficits; and Monitored for at least 1 hour after ON Q® catheter placement to ensure no immediate complications from placement or local anesthestic toxicity. |
Patient will be followed for the duration of hospital stay, 1 week | No |
| Secondary | 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 | No |