Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System (ON-Q)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Rib Fractures	Device: ON-Q bupivicaine administration; Drug: IV opioid administration	Phase 4

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Active Comparator: IV opioids alone; Standard therapy with IV opioid administration	Drug: IV opioid administration; Patient controlled analgesia with IV narcotics; Other Name: PCA, morphine

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103

Sponsors and Collaborators

The Cooper Health System

Investigators

Principal Investigator:	Cynthia R Fusco, DO	The Cooper Health System

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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