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| Sponsored by: |
Cooper University Hospital |
|---|---|
| Information provided by: | Cooper University Hospital |
| ClinicalTrials.gov Identifier: | NCT00880529 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rib Fractures |
Device: ON-Q bupivicaine administration Drug: IV opioid administration |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| 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 Rib Fractures |
| Estimated Enrollment: | 48 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
ON-Q: Experimental
Subcutaneous bupivicaine administration and IV opioid medication if necessary
|
Device: ON-Q bupivicaine administration
continuous subcutaneous bupivicaine drip
|
|
IV opioids alone: Active Comparator
Standard therapy with IV opioid administration
|
Drug: IV opioid administration
Patient controlled analgesia with IV narcotics
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cynthia R Fusco, DO | 856-968-7210 | fusco-cynthia@cooperhealth.edu |
| Contact: Mary T. Lachant, MPA | 856-968-7210 | lachant-mary@cooperhealth.edu |
| United States, New Jersey | |
| Cooper University Hospital | Recruiting |
| Camden, New Jersey, United States, 08103 | |
| Sub-Investigator: Michael E. Goldberg, MD | |
| Principal Investigator: | Cynthia R Fusco, DO | Cooper University Hospital |
More Information
| Responsible Party: | Cooper health system ( Cynthia Fusco DO Trauma Surgeon ) |
| Study ID Numbers: | 07-118 |
| Study First Received: | April 10, 2009 |
| Last Updated: | April 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00880529 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
rib fractures ventilator ON-Q analgesia |
|
Morphine Rib Fractures Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Anesthetics Central Nervous System Depressants |
Pain Narcotics Anesthetics, Local Thoracic Injuries Bupivacaine Peripheral Nervous System Agents |
|
Rib Fractures Fractures, Bone Physiological Effects of Drugs Wounds and Injuries Disorders of Environmental Origin Anesthetics Central Nervous System Depressants Anesthetics, Local |
Pharmacologic Actions Thoracic Injuries Sensory System Agents Therapeutic Uses Bupivacaine Peripheral Nervous System Agents Central Nervous System Agents |
