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

This study has been terminated.

(low enrollment, 2 pts enrolled no data every analyzed investigator left the institution)

Sponsor:

Information provided by (Responsible Party):

Ashley Shapiro, Cooper University Hospital

ClinicalTrials.gov Identifier:

NCT00880529

First received: April 10, 2009

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Chest Injuries and Disorders Fractures

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by The Cooper Health System:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	2
Study Start Date:	February 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880529

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

No publications provided


Responsible Party:	Ashley Shapiro, Principal investigator, Cooper University Hospital
ClinicalTrials.gov Identifier:	NCT00880529 History of Changes
Other Study ID Numbers:	07-118
Study First Received:	April 10, 2009
Last Updated:	February 26, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by The Cooper Health System:


rib fractures ventilator ON-Q analgesia

Additional relevant MeSH terms:


Rib Fractures Fractures, Bone Thoracic Injuries Wounds and Injuries Bupivacaine Anesthetics Anesthetics, Local	Central Nervous System Agents Central Nervous System Depressants Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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