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

Study Overview
=================
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.

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

Conditions
-----------------
Rib Fractures

Intervention / Treatment
-----------------
* Device: ON-Q bupivicaine administration
* Drug: IV opioid administration


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ON-Q<br>Subcutaneous bupivicaine administration and IV opioid medication if necessary | Device: ON-Q bupivicaine administration<br>* continuous subcutaneous bupivicaine drip<br>* Other names: ON-Q, bupivicaine;|
| Active Comparator: IV opioids alone<br>Standard therapy with IV opioid administration | Drug: IV opioid administration<br>* Patient controlled analgesia with IV narcotics<br>* Other names: PCA, morphine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from weaning process initiation to discontinuation of ventilatory support |  | Time will be measured in hours from initation of ventilator weaning to no ventilatory support needed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | each 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rib fractures, ventilator, ON-Q, analgesia