Rib FracturesPhase 4ON-QNCT00880529
Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System
A Phase 4 study testing ON-Q bupivicaine administration and IV opioid administration in people with Rib Fractures, run by The Cooper Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures
- What is being tested?
- ON-Q bupivicaine administration and IV opioid administration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- 3 or more rib fractures
- Intubated ready for weaning from ventilator support
- FI02 < 50%
- Peep < 10cm H2O
Who cannot join
- < 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 locations and contacts
1 site in 1 country.
United States1 site
Cooper University Hospital
Camden, New Jersey, 08103
About this study
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
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
- Being tested
- ON-Q bupivicaine administration, IV opioid administration
- Keywords
- rib fractures, ventilator, ON-Q, analgesia
- Medical subject headings
- Rib Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ON-Q bupivicaine administrationDevice
Also called ON-Q, bupivicaine
continuous subcutaneous bupivicaine drip
IV opioid administrationDrug
Also called PCA, morphine
Patient controlled analgesia with IV narcotics
| Study group | Role | What they receive |
|---|---|---|
| ON-Q | Experimental | Subcutaneous bupivicaine administration and IV opioid medication if necessary Receives: Device: ON-Q bupivicaine administration |
| IV opioids alone | Active comparator | Standard therapy with IV opioid administration Receives: Drug: IV opioid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from weaning process initiation to discontinuation of ventilatory support
Measured: 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.
Measured: each 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: low enrollment, 2 pts enrolled no data every analyzed investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Shapiro, The Cooper Health System
- Investigators
- Cynthia R Fusco, DO, Principal investigator, The Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880529
- Sponsor's protocol ID
- 07-118
- Acronym
- ON-Q
- Status last verified
- Feb 2013
- First submitted
- 10 Apr 2009
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00880529
- Acronym / sponsor ID
- ON-Q / 07-118
- Conditions
- Rib Fractures
- Keywords
- rib fractures, ventilator, ON-Q, analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment, 2 pts enrolled no data every analyzed investigator left the institution
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ON-Q | Experimental | Device: ON-Q bupivicaine administrationSubcutaneous bupivicaine administration and IV opioid medication if necessary |
| IV opioids alone | Active comparator | Drug: IV opioid administrationStandard therapy with IV opioid administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 18 years of age
- 3 or more rib fractures
- Intubated ready for weaning from ventilator support
- FI02 < 50%
- Peep < 10cm H2O
Key exclusion criteria (7 listed)
- < 18 years of age
- Pregnant
- Unable to communicate pain status
- Allergy to local anesthetics
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ON-Q bupivicaine administrationAlso: ON-Q, bupivicainecontinuous subcutaneous bupivicaine drip | Device | ON-Q |
| IV opioid administrationAlso: PCA, morphinePatient controlled analgesia with IV narcotics | Drug | IV opioids alone |
Primary outcome
Time from weaning process initiation to discontinuation of ventilatory support
Time frame: Time will be measured in hours from initation of ventilator weaning to no ventilatory support needed
1 secondary outcome
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.
Time frame: each 24 hours
Results and safety
The study was stopped early (reason given: low enrollment, 2 pts enrolled no data every analyzed investigator left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
Related trials for Rib Fractures
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RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia R Fusco, DO principal investigator
The Cooper Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ON-Q bupivicaine administration and IV opioid administration in people with Rib Fractures, run by The Cooper Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low enrollment, 2 pts enrolled no data every analyzed investigator left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from weaning process initiation to discontinuation of ventilatory support (time frame: Time will be measured in hours from initation of ventilator weaning to no ventilatory support needed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.