Rib FracturesNCT02604589
Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures
A study testing hydromorphone hydrochloride, Infusion catheter placement and bupivicaine 0.25% in people with Rib Fractures, run by Anthony Iacco at 1 site in United States.
Trial summary
Rib fractures are common injuries in accident patients and can be associated with significant pain during recovery. If poorly controlled, pain from splinting due to rib fractures can result in difficulty in breathing leading to incomplete expansion of lung, and even the need to put a patient on a ventilator to help… 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?
- hydromorphone hydrochloride, Infusion catheter placement and bupivicaine 0.25%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Admission to trauma service at Beaumont Hospital, Royal Oak, Michigan
- Two or more rib fractures in an anatomic pattern feasible for nerve blockade (unilateral or bilateral)
- Age greater than or equal to 18 years
- Ability to comprehend and endorse an informed consent
Who cannot join
- Patients who are pregnant or breastfeeding
- Patients intubated before placement of continuous infusion catheter
- Any significant concomitant injuries potentially confounding for evaluation of the effectiveness of analgesia (eg., traumatic brain injury)
- History of an allergic reaction to local anesthetic
- Use of other regional anesthetics before evaluation (epidural or paravertebral nerve blockade)
- International Normalized Ratio (INR) > 2.0
- Inability to obtain informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: Prime "Rib" Time: Randomized Control Trial Evaluating the Use of Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures
Rib fractures are common injuries in accident patients and can be associated with significant pain during recovery. If poorly controlled, pain from splinting due to rib fractures can result in difficulty in breathing leading to incomplete expansion of lung, and even the need to put a patient on a ventilator to help them breathe. Therefore, pain control is critical in managing patients with rib fractures. To date, many studies have shown the effectiveness of continuous intercostal nerve blockade (a slow release of pain medications at the site of injury that prevents the transmission of pain signals). This approach has never been studied in a randomized fashion in rib fracture patients, and has never been compared to patient-controlled narcotic pain medication, commonly used at many hospitals. The purpose of this study is to evaluate the effectiveness of the placement of an elastomeric infusion pump (a small, external, wearable balloon used to deliver medication over time) attached to a continuous infusion catheter or "soaker" catheter (a tube which releases the pain medication through tiny holes in it, right at the site of injury) to deliver local anesthetic medication to reduce pain caused by two or more rib fractures.
Read the detailed description
Treatment of rib fractures using an elastomeric infusion pump (a small, external, wearable balloon used to deliver medication over time) containing pain medication and a continuous infusion catheter or "soaker" catheter (a tube which releases the pain medication through tiny holes in it, right at the site of injury) placed in the extrathoracic paraspinous space (a site in the back that is near the broken ribs) to create a continuous intercostal nerve block is relatively novel. Truitt and colleagues have published two studies evaluating the effectiveness of this approach. A pilot study on 30 patients was published in 2010 showing that placement of these catheters was a safe, viable and effective procedure, and resulted in decreased pain scores in rib fracture patients. A second study included 102 patients studied prospectively (from the time of admission to the hospital) comparing epidural anesthesia (an injection of anesthetic into the spine) with local catheter delivery in a non-randomized fashion in 2011. This approach is beginning to be more widely used, but has never been studied in a randomized fashion, and has never been compared to patient-controlled analgesia (PCA, delivery of a pain medication by the push of a button), commonly used at many hospitals.
We hypothesize that accident patients with two or more rib fractures who receive pain control through the continuous infusion system will achieve improved pain control in a dose-dependent fashion, improved lung function, and therefore, will require less narcotic pain medication, achieve discharge criteria earlier and have a shorter hospital length of stay in comparison to patients treated with PCA alone.
- Conditions
- Rib Fractures
- Being tested
- hydromorphone hydrochloride, Infusion catheter placement, bupivicaine 0.25%, bupivicaine 0.5%
- Keywords
- Catheters, Indwelling, Infusion Pumps, Anesthesia, Local, Analgesia, Patient-Controlled, Bupivacaine
- 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.
hydromorphone hydrochlorideDrug
Also called Dilaudid
Patient-controlled narcotic analgesia pump
Infusion catheter placementProcedure or surgery
Also called OnQ pump placement
Placement of continuous infusion catheter and elastomeric pump into extrathoracic paraspinous space
bupivicaine 0.25%Drug
Also called Marciane
Low Dose analgesia
bupivicaine 0.5%Drug
Also called Marcaine
High dose analgesia
| Study group | Role | What they receive |
|---|---|---|
| PCA only | Placebo comparator | Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr. Receives: Drug: hydromorphone hydrochloride |
| Bupivicaine 0.25% (LOW DOSE) | Experimental | Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter. Receives: Drug: hydromorphone hydrochloride; Procedure: Infusion catheter placement; Drug: bupivicaine 0.25% |
| Bupivicaine 0.5% (HIGH DOSE) | Experimental | Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter. Receives: Drug: hydromorphone hydrochloride; Procedure: Infusion catheter placement; Drug: bupivicaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic Use
Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours.
Measured: 3 days or hospital length of stay, if less than 3 days
Secondary outcomes (6)
Time to Improvement in Pulmonary Function
Determine the impact of catheter-infused medications on maximal inspiratory lung volume measured by incentive spirometer (IS) as a change from baseline at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group). Endpoint will be the time to improvement of vital capacity to greater than 1.4 liters (or 15 mL/kg).
Measured: 3 days or hospital length of stay, if less than 3 days
Time to Improvement in Pain Intensity
Determine the impact of catheter-infused medications on self-reported pain intensity reported as a change from baseline (admission) at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group) on a 0-10 point Likert scale, with 0=no pain, and 10= the worst pain ever. Response will be defined as time to a decrease of at least two points on the scale.
Measured: 3 days or hospital length of stay, if less than 3 days
Morbidity
Collection of complications observed at any point during the hospital admission that included randomization, including pneumothorax, hemothorax, acute respiratory distress syndrome, pneumonia, empyema, need for tracheostomy, need for mechanical ventilation, length of time on mechanical ventilation, and an assessment of the degree of association of each event with the catheter insertion procedure or with underlying trauma. Each of these outcomes will be scored as yes/no.
Measured: 3 days or hospital length of stay, whichever is longer
Mortality
All cause death, death associated with infusion catheter, within 30 days from date of randomization. This outcome will be scored as yes/no and cause of death will be collected.
Measured: 30 days
Hospital Length of Stay
Integer days of inpatient admission in the hospital stay that included randomization.
Measured: from randomization to discharge, usually within the range of 5-15 days
Surgical Intensive Care Unit (SICU) Length of Stay
Integer days of admission to the surgical intensive care unit. For patients not requiring admission to surgical intensive care, patient is not analyzed. Usual range is 3-5 days.
Measured: from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: resource reallocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthony Iacco
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health East
- Responsible party
- Sponsor-investigator, Anthony Iacco, Corewell Health East
- Investigators
- Anthony Iacco, MD, Principal investigator, Beaumont Hospital, Royal Oak MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604589
- Sponsor's protocol ID
- 2015-233
- Status last verified
- Apr 2017
- First submitted
- 2 Nov 2015
- Last updated
- 12 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prime "Rib" Time: Randomized Control Trial Evaluating the Use of Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures
- ClinicalTrials.gov ID
- NCT02604589
- Acronym / sponsor ID
- 2015-233
- Conditions
- Rib Fractures
- Keywords
- Catheters, Indwelling, Infusion Pumps, Anesthesia, Local, Analgesia, Patient-Controlled, Bupivacaine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: resource reallocation
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Anthony IaccoUniversity, hospital or other
- Collaborators
- Corewell Health East
- Study start
- Mar 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Posted 12 May 2017
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 common injuries in accident patients and can be associated with significant pain during recovery. If poorly controlled, pain from splinting due to rib fractures can result in difficulty in breathing leading to incomplete expansion of lung, and even the need to put a patient on a ventilator to help them breathe. Therefore, pain control is critical in managing patients with rib fractures. To date, many studies have shown the effectiveness of continuous intercostal nerve blockade (a slow release of pain medications at the site of injury that prevents the transmission of pain signals). This approach has never been studied in a randomized fashion in rib fracture patients, and has never been compared to patient-controlled narcotic pain medication, commonly used at many hospitals. The purpose of this study is to evaluate the effectiveness of the placement of an elastomeric infusion pump (a small, external, wearable balloon used to deliver medication over time) attached to a continuous infusion catheter or "soaker" catheter (a tube which releases the pain medication through tiny holes in it, right at the site of injury) to deliver local anesthetic medication to reduce pain caused by two or more rib fractures.
Detailed description
Treatment of rib fractures using an elastomeric infusion pump (a small, external, wearable balloon used to deliver medication over time) containing pain medication and a continuous infusion catheter or "soaker" catheter (a tube which releases the pain medication through tiny holes in it, right at the site of injury) placed in the extrathoracic paraspinous space (a site in the back that is near the broken ribs) to create a continuous intercostal nerve block is relatively novel. Truitt and colleagues have published two studies evaluating the effectiveness of this approach. A pilot study on 30 patients was published in 2010 showing that placement of these catheters was a safe, viable and effective procedure, and resulted in decreased pain scores in rib fracture patients. A second study included 102 patients studied prospectively (from the time of admission to the hospital) comparing epidural anesthesia (an injection of anesthetic into the spine) with local catheter delivery in a non-randomized fashion in 2011. This approach is beginning to be more widely used, but has never been studied in a randomized fashion, and has never been compared to patient-controlled analgesia (PCA, delivery of a pain medication by the push of a button), commonly used at many hospitals.
We hypothesize that accident patients with two or more rib fractures who receive pain control through the continuous infusion system will achieve improved pain control in a dose-dependent fashion, improved lung function, and therefore, will require less narcotic pain medication, achieve discharge criteria earlier and have a shorter hospital length of stay in comparison to patients treated with PCA alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCA only | Placebo comparator | Drug: hydromorphone hydrochlorideProcedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr. |
| Bupivicaine 0.25% (LOW DOSE) | Experimental | Drug: hydromorphone hydrochloride, Procedure: Infusion catheter placement, Drug: bupivicaine 0.25%Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr. Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter. |
| Bupivicaine 0.5% (HIGH DOSE) | Experimental | Drug: hydromorphone hydrochloride, Procedure: Infusion catheter placement, Drug: bupivicaine 0.5%Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr. Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission to trauma service at Beaumont Hospital, Royal Oak, Michigan
- Two or more rib fractures in an anatomic pattern feasible for nerve blockade (unilateral or bilateral)
- Age greater than or equal to 18 years
- Ability to comprehend and endorse an informed consent
Key exclusion criteria (7 listed)
- Patients who are pregnant or breastfeeding
- Patients intubated before placement of continuous infusion catheter
- Any significant concomitant injuries potentially confounding for evaluation of the effectiveness of analgesia (eg., traumatic brain injury)
- History of an allergic reaction to local anesthetic
- Use of other regional anesthetics before evaluation (epidural or paravertebral nerve blockade)
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 |
|---|---|---|
| hydromorphone hydrochlorideAlso: DilaudidPatient-controlled narcotic analgesia pump | Drug | Bupivicaine 0.25% (LOW DOSE), Bupivicaine 0.5% (HIGH DOSE), PCA only |
| Infusion catheter placementAlso: OnQ pump placementPlacement of continuous infusion catheter and elastomeric pump into extrathoracic paraspinous space | Procedure or surgery | Bupivicaine 0.25% (LOW DOSE), Bupivicaine 0.5% (HIGH DOSE) |
| bupivicaine 0.25%Also: MarcianeLow Dose analgesia | Drug | Bupivicaine 0.25% (LOW DOSE) |
| bupivicaine 0.5%Also: MarcaineHigh dose analgesia | Drug | Bupivicaine 0.5% (HIGH DOSE) |
Primary outcome
Narcotic Use
Time frame: 3 days or hospital length of stay, if less than 3 days
Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours.
6 secondary outcomes
Time to Improvement in Pulmonary Function
Time frame: 3 days or hospital length of stay, if less than 3 days
Time to Improvement in Pain Intensity
Time frame: 3 days or hospital length of stay, if less than 3 days
Morbidity
Time frame: 3 days or hospital length of stay, whichever is longer
Mortality
Time frame: 30 days
Hospital Length of Stay
Time frame: from randomization to discharge, usually within the range of 5-15 days
Surgical Intensive Care Unit (SICU) Length of Stay
Time frame: from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Anthony Iacco, MD principal investigator
Beaumont Hospital, Royal Oak MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydromorphone hydrochloride, Infusion catheter placement and bupivicaine 0.25% in people with Rib Fractures, run by Anthony Iacco 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 4 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 12 May 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 12 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Narcotic Use (time frame: 3 days or hospital length of stay, if less than 3 days). 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 12 May 2017.