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

Rib Fractures Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00880529
• Other study ID #: 07-118
• Status: Terminated
• Phase: Phase 4
• First received: April 10, 2009
• Last updated: February 26, 2013
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: February 2013
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Device:
• ON-Q bupivicaine administration
continuous subcutaneous bupivicaine drip

Drug:
• IV opioid administration
Patient controlled analgesia with IV narcotics

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No