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

Primary Purpose

Rib Fractures

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ON-Q bupivicaine administration
IV opioid administration
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures focused on measuring rib fractures, ventilator, ON-Q, analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cooper University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ON-Q

IV opioids alone

Arm Description

Subcutaneous bupivicaine administration and IV opioid medication if necessary

Standard therapy with IV opioid administration

Outcomes

Primary Outcome Measures

Time from weaning process initiation to discontinuation of ventilatory support

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.

Full Information

First Posted
April 10, 2009
Last Updated
February 26, 2013
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00880529
Brief Title
Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System
Acronym
ON-Q
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
low enrollment, 2 pts enrolled no data every analyzed investigator left the institution
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cooper Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures
Keywords
rib fractures, ventilator, ON-Q, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ON-Q
Arm Type
Experimental
Arm Description
Subcutaneous bupivicaine administration and IV opioid medication if necessary
Arm Title
IV opioids alone
Arm Type
Active Comparator
Arm Description
Standard therapy with IV opioid administration
Intervention Type
Device
Intervention Name(s)
ON-Q bupivicaine administration
Other Intervention Name(s)
ON-Q, bupivicaine
Intervention Description
continuous subcutaneous bupivicaine drip
Intervention Type
Drug
Intervention Name(s)
IV opioid administration
Other Intervention Name(s)
PCA, morphine
Intervention Description
Patient controlled analgesia with IV narcotics
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia R Fusco, DO
Organizational Affiliation
The Cooper Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

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

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