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low enrollment, 2 pts enrolled no data every analyzed investigator left the institution
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ON-Q | Experimental | Subcutaneous bupivicaine administration and IV opioid medication if necessary |
|
| IV opioids alone | Active Comparator | Standard therapy with IV opioid administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ON-Q bupivicaine administration | Device | continuous subcutaneous bupivicaine drip |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from weaning process initiation to discontinuation of ventilatory support | Time will be measured in hours from initation of ventilator weaning to no ventilatory support needed |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | each 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia R Fusco, DO | The Cooper Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D010323 | Passive Cutaneous Anaphylaxis |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| IV opioid administration | Drug | Patient controlled analgesia with IV narcotics |
|
|
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |