MedTrace Logo

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

NCT00880529 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2013-02-27

No results posted yet for this study

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

Interventions

DEVICE

ON-Q bupivicaine administration

continuous subcutaneous bupivicaine drip

DRUG

IV opioid administration

Patient controlled analgesia with IV narcotics

Sponsors & Collaborators

  • The Cooper Health System

    lead OTHER

Principal Investigators

  • Cynthia R Fusco, DO · The Cooper Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00880529 on ClinicalTrials.gov