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

February 26, 2013 updated by: Ashley Shapiro, The Cooper Health System

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • PCA, morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time will be measured in hours from initation of ventilator weaning to no ventilatory support needed

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: each 24 hours
each 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cooper Health System

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimate)

April 13, 2009

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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