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resource reallocation
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| Name | Class |
|---|---|
| Corewell Health East | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydromorphone hydrochloride | Drug | Patient-controlled narcotic analgesia pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Use | Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours. | 3 days or hospital length of stay, if less than 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Iacco, MD | Beaumont Hospital, Royal Oak MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital - Royal Oak | Royal Oak | Michigan | 48073 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PCA Only | 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. |
| FG001 | Bupivicaine 0.25% (LOW DOSE) | bupivicaine 0.25%: Low Dose analgesia 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. PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter. |
| FG002 | Bupivicaine 0.5% (HIGH DOSE) | bupivicaine 0.5%: High dose analgesia 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. PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PCA Only | 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. |
| BG001 | Bupivicaine 0.25% (LOW DOSE) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Narcotic Use | Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours. | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group | Posted | Mean | Standard Deviation | mg/24 hours over days 1-3 | 3 days or hospital length of stay, if less than 3 days |
|
Adverse events were collected from enrollment through the first 3 days of hospitalization.
An assessment of medical records and case report forms were examined for Adverse Events or Serious Adverse Events. Reports were reviewed by the PI for accuracy and relation to study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCA Only | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | No source vocabulary | Non-systematic Assessment |
Study terminated early due to lack of enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rose Callahan | William Beaumont Hospital | 248 551-5147 | rose.callahan@beaumont.org |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| Infusion catheter placement | Procedure | Placement of continuous infusion catheter and elastomeric pump into extrathoracic paraspinous space |
|
|
| bupivicaine 0.25% | Drug | Low Dose analgesia |
|
|
| bupivicaine 0.5% | Drug | High dose analgesia |
|
|
| 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. | 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. | 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. | 30 days |
| Hospital Length of Stay | Integer days of inpatient admission in the hospital stay that included randomization. | 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. | from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit |
bupivicaine 0.25%: Low Dose analgesia 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. PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter. |
| BG002 | Bupivicaine 0.5% (HIGH DOSE) | bupivicaine 0.5%: High dose analgesia 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. PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Ribs Fractured | Mean | Standard Deviation | ribs |
|
| Admission Incentive Spirometry (IS) Volume | Maximal inspiratory lung volume measured by incentive spirometer (IS) | Mean | Standard Deviation | cc |
|
| Admission Pain Score | Analog pain scale of 1-10, where 1= no pain and 10= worst pain ever | Median | Full Range | units on a scale |
|
| OG002 | Bupivicaine 0.5% (HIGH DOSE) | bupivicaine 0.5%: High dose analgesia 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. PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter. |
|
|
| Secondary | 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). | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one member to analyze; therefore standard deviation = 0. | Posted | Mean | Standard Deviation | days | 3 days or hospital length of stay, if less than 3 days |
|
|
|
| Secondary | 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. | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. Only one subject remains to be analyzed in that group so standard deviation = 0 | Posted | Mean | Standard Deviation | days | 3 days or hospital length of stay, if less than 3 days |
|
|
|
| Secondary | 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. | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group | Posted | Number | number of complications | 3 days or hospital length of stay, whichever is longer |
|
|
|
| Secondary | 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. | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Hospital Length of Stay | Integer days of inpatient admission in the hospital stay that included randomization. | One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one subject to analyze, so standard deviation =0 | Posted | Mean | Standard Deviation | days | from randomization to discharge, usually within the range of 5-15 days |
|
|
|
| Secondary | 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. | Only patients analyzed who had surgical intensive care unit admission. | Posted | Mean | Standard Deviation | days | from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Bupivicaine 0.25% (LOW DOSE) | bupivicaine 0.25%: Low Dose analgesia 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. PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter. | 0 | 5 | 2 | 5 |
| EG002 | Bupivicaine 0.5% (HIGH DOSE) | bupivicaine 0.5%: High dose analgesia 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. PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter. | 0 | 1 | 0 | 1 |
| Low urine output | Renal and urinary disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
|
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| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |