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NCT00880529 · ClinicalTrials.gov registry record · Phase 4
Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System
A Phase 4 study, sponsored by The Cooper Health System.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT00880529 is a Phase 4 study that was terminated before completion, run by The Cooper Health System. The registered enrollment target is 2 participants.
The verdict
NCT00880529, a Phase 4 study, was terminated before completion, sponsored by The Cooper Health System.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- DEVICE ON-Q bupivicaine administration
- DRUG IV opioid administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00880529
The ClinicalTrials.gov registry entry for NCT00880529 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cooper Health System, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ON-Q bupivicaine administration is the first listed.
NCT00880529 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00880529 about?
NCT00880529 is a clinical study titled "Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System". 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...
What is the current status of trial NCT00880529?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2009-02. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00880529?
The interventions under investigation include: ON-Q bupivicaine administration (DEVICE), IV opioid administration (DRUG).
Who is sponsoring clinical trial NCT00880529?
This trial is sponsored by The Cooper Health System, which has 39 total clinical trials registered on ClinicalTrials.gov.
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