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

Phase 4

Terminated

• Conditions: Rib Fractures
• Interventions: Device: ON-Q bupivicaine administration; Drug: IV opioid administration

• Registration Number: NCT00880529
• Lead Sponsor: The Cooper Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-13
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ON-Q	ON-Q bupivicaine administration	Subcutaneous bupivicaine administration and IV opioid medication if necessary
IV opioids alone	IV opioid administration	Standard therapy with IV opioid administration

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States