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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: Fractures
U.S. FDA Resources

Further study details as provided by Cooper University Hospital:

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
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
Cooper University Hospital
Investigators
Principal Investigator: Cynthia R Fusco, DO Cooper University Hospital
  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 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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics

ClinicalTrials.gov processed this record on May 22, 2013