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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00880529

Acronym

ON-Q

Enrollment

Registered

2009-04-13

Start date

2009-02-28

Completion date

2011-05-31

Last updated

2013-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rib Fractures

Keywords

rib fractures, ventilator, ON-Q, analgesia

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.

Interventions

DEVICEON-Q bupivicaine administration

continuous subcutaneous bupivicaine drip

DRUGIV opioid administration

Patient controlled analgesia with IV narcotics

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026