Clinical Trial: Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Does Continuous Subcutaneous Paravertebral Infusion of Bupivicaine With the ON-Q Pain Relief System vs. Standard IV Pain Management Decrease Ventilator Dependence in Trauma Patients With Multiple
Brief Summary:
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.
Detailed Summary:
Sponsor: The Cooper Health System
Current Primary Outcome: Time from weaning process initiation to discontinuation of ventilatory support [ Time Frame: Time will be measured in hours from initation of ventilator weaning to no ventilatory support needed ]
Original Primary Outcome: Same as current
Current Secondary Outcome: total dose of narcotics given will be identified and reported as mcg or mg each 24 hour period that ON-Q pain pump is being used. [ Time Frame: each 24 hours ]
Original Secondary Outcome: Same as current
Information By: The Cooper Health System
Dates:
Date Received: April 10, 2009
Date Started: February 2009
Date Completion:
Last Updated: February 26, 2013
Last Verified: February 2013
