Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System
Stopped early · Phase 4
Conditions studied: Rib Fractures
In brief
The purpose of this study is to find out if patients having the ON-Q post-op Pain Relief System for pain management of multiple rib fractures will require fewer ventilator days, and will need less IV pain medicine to control their pain, and as a result have improved respiratory function during their recovery. The standard of care for providing pain relief for rib fractures is to use an opioid drug that is injected into the vein but also has side effects. Increased doses can lead to over sedation and consequently lead to difficulty with breathing. The ON-Q pain relief systems uses a local anesthetic under the skin. The anesthetic is called bupivicaine, and it is delivered from a thin tube approximately 10 inches long is tunneled under the skin along the back and parallel to the spine. The medication is stored in an elastic pump which delivers a slow continuous drip of medication from multiple holes in the tubing. Subjects will be randomized to either standard intravenous opioid pain management or the ON-Q pain relief device with supplemental opioid medication if needed. The device will remain in use until the subjects are able to breathe without the ventilator.
Key facts
- Study ID
- NCT00880529
- Run by
- The Cooper Health System
- People needed
- 2
- Starts
- 2009-02-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2013-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- > 18 years of age
- 3 or more rib fractures
- Intubated ready for weaning from ventilator support
- FI02 < 50%
- Peep < 10cm H2O
You may not qualify if…
- < 18 years of age
- Pregnant
- Unable to communicate pain status
- Allergy to local anesthetics
- Coagulopathy
- Skin lesions or abnormalities from previous injury or surgery
- < 3 rib fractures
Where it is running
- Cooper University Hospital — Camden, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.