Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System (ON-Q)
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ClinicalTrials.gov Identifier: NCT00880529 |
Recruitment Status
:
Terminated
(low enrollment, 2 pts enrolled no data every analyzed investigator left the institution)
First Posted
: April 13, 2009
Last Update Posted
: February 27, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rib Fractures | Device: ON-Q bupivicaine administration Drug: IV opioid administration | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: ON-Q
Subcutaneous bupivicaine administration and IV opioid medication if necessary
|
Device: ON-Q bupivicaine administration
continuous subcutaneous bupivicaine drip
Other Name: ON-Q, bupivicaine
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Active Comparator: IV opioids alone
Standard therapy with IV opioid administration
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Drug: IV opioid administration
Patient controlled analgesia with IV narcotics
Other Name: PCA, morphine
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 18 years of age
- 3 or more rib fractures
- Intubated ready for weaning from ventilator support
- FI02 < 50%
- Peep < 10cm H2O
Exclusion Criteria:
- < 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880529
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103 |
Principal Investigator: | Cynthia R Fusco, DO | The Cooper Health System |
Responsible Party: | Ashley Shapiro, Principal investigator, Cooper University Hospital |
ClinicalTrials.gov Identifier: | NCT00880529 History of Changes |
Other Study ID Numbers: |
07-118 |
First Posted: | April 13, 2009 Key Record Dates |
Last Update Posted: | February 27, 2013 |
Last Verified: | February 2013 |
Keywords provided by Ashley Shapiro, Cooper University Hospital:
rib fractures ventilator ON-Q analgesia |
Additional relevant MeSH terms:
Fractures, Bone Rib Fractures Wounds and Injuries Thoracic Injuries Bupivacaine Analgesics, Opioid Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Narcotics Analgesics |