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

Cooper University Health Care

Status and phase: Terminated; Phase 4

Conditions: Rib Fractures

Treatments: Drug: IV opioid administration; Device: ON-Q bupivicaine administration

Study type: Interventional

Funder types: Other

Identifiers

NCT00880529

07-118

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

ON-Q

Experimental group

Description:

Subcutaneous bupivicaine administration and IV opioid medication if necessary

Treatment:

Device: ON-Q bupivicaine administration

IV opioids alone

Active Comparator group

Description:

Standard therapy with IV opioid administration

Treatment:

Drug: IV opioid administration