3 or More Rib FracturesNCT01401712
Optimal Method of Pain Management in Patients With Multiple Rib Fractures
A study testing ON-Q® Pain Relief System and Thoracic epidural catheter in people with 3 or More Rib Fractures, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. Hence, it is crucial to manage pain associated with rib fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 3 or More Rib Fractures
- What is being tested?
- ON-Q® Pain Relief System and Thoracic epidural catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2014
- Phase
- Interventional
- 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
- Age ≥ 18 years;
- Three or more rib fractures;
- Pain
- Severe pain (i.e. causing deleterious affect on respiratory mechanics, respiratory rate, or oxygen saturations), OR
- Mild to moderate pain (i.e. minimally affecting respiratory mechanics, respiratory rate, or oxygen saturations) that does not respond to oral or intravenous analgesics within 4 hours;
- Patient has capacity to provide informed consent, as determined by:
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- Clinical assessment by study staff MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD;
- GCS 15;
- Clinical assessment by independent MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD.
Who cannot join
- Lack capacity to provide informed consent;
- Intubation at time of enrollment;
- Contraindications to procedure (e.g. known allergy to local anesthetics).
- Presence of infection at site of catheter placement;
- Current use of anticoagulant medication;
- Known allergy to silver;
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- Inability to obtain informed consent;
- Body weight > 300 lbs;
- Pregnancy;
- Significant co-morbid medical illness that might alter the metabolism of the anesthetic agents and result in unexpected toxicity (hepatic, renal or cardiopulmonary disease).
- All women of child-bearing age will receive a urine pregnancy test prior to the start of the interventional portion of the study. A positive test result excludes the patient from inclusion in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Katharine M Koury, BA, 617-643-7095, kkoury@partners.org
George C Velmahos, MD, PhD
About this study
Official title: Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures
Rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are used to treat the pain, but placement can be risky as rib fractures are often associated with other injuries and complications.
An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved device that automatically and continuously delivers medication to the region of the thoracic intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system effectively reduced pain and increased lung volumes after one hour, in patients with three or more rib fractures. However, that study sample was small and did not have a comparison group. In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We hypothesize that trauma patients with three or more rib fractures, who receive pain management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus have a shorter hospital length of stay (LOS) when compared with epidural analgesia.
- Conditions
- 3 or More Rib Fractures
- Being tested
- ON-Q® Pain Relief System, Thoracic epidural catheter
- Keywords
- ON-Q, epidural, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ON-Q® Pain Relief SystemProcedure or surgery
Identify insertion site lateral to paraspinous muscles and posteromedial to the rib fractures. Then, incise skin and soft tissue down to the level of the rib. Advance tunneler perpendicular to chest wall until it contacts the rib, then, advance superiorly at 45° angle in the extrathoracic space. Remove tunneler and advance catheter in space created. Attach catheter to pump filled with 0.2% ropivacaine at infusion rate of 2-12ml/hr.
Thoracic epidural catheterProcedure or surgery
Introduce needle into the interspinous space of the vertebral column and advance into the epidural space. Advance the epidural catheter about 3-5 cm into the epidural space and remove the needle.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral catheter (ON-Q® Pain Relief System) | Experimental | Not described Receives: Procedure: ON-Q® Pain Relief System |
| Thoracic epidural catheter | Active comparator | Not described Receives: Procedure: Thoracic epidural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay/time to achieve discharge criteria
The study will compare the time to achieve discharge criteria between the two groups. Readiness for discharge is defined by the following criteria:
- Visual Analog Score (VAS) for pain below 4 (of a maximum 10);
- Ability to perform incentive spirometry with sustained maximal inspiration for three seconds;
- Hemodynamic stability (heart rate <100 beats/min, respiratory rate <20 breaths/min, and systolic blood pressure >90mmHg at 3 consecutive time points that are 10 minutes apart) and oxygen saturation greater than 95% on room air;
- Absence of neurological deficits; and
- Monitored for at least 1 hour after ON Q® catheter placement to ensure no immediate complications from placement or local anesthestic toxicity.
Measured: Patient will be followed for the duration of hospital stay, 1 week
Secondary outcomes (1)
Pain score reduction
Decrease in pain as measured by the Visual Analog Scale (VAS) pre-placement and 60 min post-placement of intervention. Pain score will be followed for the duration of the intervention.
Measured: Patient will be followed for duration of hospital stay and through daily phone calls upon discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startOct 2012
- Primary completionApr 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 3 or More Rib FracturesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- I-Flow
- Responsible party
- Principal investigator, George Velmahos, Massachusetts General Hospital
- Investigators
- George C Velmahos, Md, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401712
- Sponsor's protocol ID
- 2011P001678
- Status last verified
- Oct 2013
- First submitted
- 21 Jul 2011
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Truitt MS, Mooty RC, Amos J, Lorenzo M, Mangram A, Dunn E. Out with the old, in with the new: a novel approach to treating pain associated with rib fractures. World J Surg. 2010 Oct;34(10):2359-62. doi: 10.1007/s00268-010-0651-9.
PubMed 20567973
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures
- ClinicalTrials.gov ID
- NCT01401712
- Acronym / sponsor ID
- 2011P001678
- Conditions
- 3 or More Rib Fractures
- Keywords
- ON-Q, epidural, analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- I-Flow
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 25 Jul 2011 (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.
Rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are used to treat the pain, but placement can be risky as rib fractures are often associated with other injuries and complications.
An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved device that automatically and continuously delivers medication to the region of the thoracic intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system effectively reduced pain and increased lung volumes after one hour, in patients with three or more rib fractures. However, that study sample was small and did not have a comparison group. In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We hypothesize that trauma patients with three or more rib fractures, who receive pain management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus have a shorter hospital length of stay (LOS) when compared with epidural analgesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral catheter (ON-Q® Pain Relief System) | Experimental | Procedure: ON-Q® Pain Relief System |
| Thoracic epidural catheter | Active comparator | Procedure: Thoracic epidural catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years;
- Three or more rib fractures;
- Pain
- Patient has capacity to provide informed consent, as determined by:
Key exclusion criteria (11 listed)
- Lack capacity to provide informed consent;
- Intubation at time of enrollment;
- Contraindications to procedure (e.g. known allergy to local anesthetics).
- Presence of infection at site of catheter placement;
- Current use of anticoagulant medication;
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® Pain Relief SystemIdentify insertion site lateral to paraspinous muscles and posteromedial to the rib fractures. Then, incise skin and soft tissue down to the level of the rib. Advance tunneler perpendicular to chest wall until it contacts the rib, then, advance superiorly at 45° angle in the extrathoracic space. Remove tunneler and advance catheter in space created. Attach catheter to pump filled with 0.2% ropivacaine at infusion rate of 2-12ml/hr. | Procedure or surgery | Paravertebral catheter (ON-Q® Pain Relief System) |
| Thoracic epidural catheterIntroduce needle into the interspinous space of the vertebral column and advance into the epidural space. Advance the epidural catheter about 3-5 cm into the epidural space and remove the needle. | Procedure or surgery | Thoracic epidural catheter |
Primary outcome
Hospital length of stay/time to achieve discharge criteria
Time frame: Patient will be followed for the duration of hospital stay, 1 week
The study will compare the time to achieve discharge criteria between the two groups. Readiness for discharge is defined by the following criteria: 1. Visual Analog Score (VAS) for pain below 4 (of a maximum 10); 2. Ability to perform incentive spirometry with sustained maximal inspiration for three seconds; 3. Hemodynamic stability (heart rate <100 beats/min, respiratory rate <20 breaths/min, and systolic blood pressure >90mmHg at 3 consecutive time points that are 10 minutes apart) and oxygen saturation greater than 95% on room air; 4. Absence of neurological deficits; and 5. Monitored for at least 1 hour after ON Q® catheter placement to ensure no immediate complications from placement or local anesthestic toxicity.
1 secondary outcome
Pain score reduction
Time frame: Patient will be followed for duration of hospital stay and through daily phone calls upon discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Background: PubMed 20567973Truitt MS, Mooty RC, Amos J, Lorenzo M, Mangram A, Dunn E. Out with the old, in with the new: a novel approach to treating pain associated with rib fractures. World J Surg. 2010 Oct;34(10):2359-62. doi: 10.1007/s00268-010-0651-9.
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.
George C Velmahos, Md, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ON-Q® Pain Relief System and Thoracic epidural catheter in people with 3 or More Rib Fractures, run by Massachusetts General Hospital 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 29 Oct 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katharine M Koury, BA (617-643-7095, kkoury@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay/time to achieve discharge criteria (time frame: Patient will be followed for the duration of hospital stay, 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01401712, which also lists 1 linked publication.
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 29 Oct 2013.