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

NCT00880529 | Terminated Phase 4

• 1 other identifier: 07-118
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures

Keywords

rib fractures; ventilator; ON-Q; analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

ON-Q

EXPERIMENTAL

Subcutaneous bupivicaine administration and IV opioid medication if necessary

Device: ON-Q bupivicaine administration

IV opioids alone

ACTIVE COMPARATOR

Standard therapy with IV opioid administration

Drug: IV opioid administration

Interventions

ON-Q bupivicaine administration DEVICE

continuous subcutaneous bupivicaine drip

Also known as: ON-Q, bupivicaine

ON-Q

IV opioid administration DRUG

Patient controlled analgesia with IV narcotics

Also known as: PCA, morphine

IV opioids alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age
• or more rib fractures
• Intubated ready for weaning from ventilator support
• FI02 \< 50%
• Peep \< 10cm H2O

You may not qualify if:

• \< 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Rib Fractures; Agnosia

Interventions

Passive Cutaneous Anaphylaxis; Morphine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Cynthia R Fusco, DO

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 13, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

US (1)