Rib Fractures
Conditions
Keywords
Catheters, Indwelling, Infusion Pumps, Anesthesia, Local, Analgesia, Patient-Controlled, Bupivacaine
Brief 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 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.
Interventions
Patient-controlled narcotic analgesia pump
PROCEDUREInfusion catheter placement
Placement of continuous infusion catheter and elastomeric pump into extrathoracic paraspinous space
Low Dose analgesia
DRUGbupivicaine 0.5%
High dose analgesia
Sponsors
Corewell Health East
Anthony Iacco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Use | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Intensive Care Unit (SICU) Length of Stay | from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit | 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. |
| Time to Improvement in Pulmonary Function | 3 days or hospital length of stay, if less than 3 days | 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). |
| Hospital Length of Stay | from randomization to discharge, usually within the range of 5-15 days | Integer days of inpatient admission in the hospital stay that included randomization. |
| Morbidity | 3 days or hospital length of stay, whichever is longer | 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. |
| Mortality | 30 days | 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. |
| Time to Improvement in Pain Intensity | 3 days or hospital length of stay, if less than 3 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 5 |
| 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. | 2 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | catheter dislodgement | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Bupivicaine 0.5% (HIGH DOSE) | Bupivicaine 0.25% (LOW DOSE) | PCA Only |
|---|---|---|---|---|
| Admission Incentive Spirometry (IS) Volume | 998 cc STANDARD_DEVIATION 696 | 1567 cc STANDARD_DEVIATION 818 | 783 cc STANDARD_DEVIATION 630 | 978 cc STANDARD_DEVIATION 563 |
| Admission Pain Score | 8 units on a scale | 7 units on a scale | 8 units on a scale | 8 units on a scale |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 1 Participants | 3 Participants | 2 Participants |
| Age, Continuous | 61.40 years STANDARD_DEVIATION 18.52 | 63.50 years STANDARD_DEVIATION 6.36 | 60.40 years STANDARD_DEVIATION 24.93 | 61.67 years STANDARD_DEVIATION 16.56 |
| Number of Ribs Fractured | 5.7 ribs STANDARD_DEVIATION 2.9 | 5.0 ribs STANDARD_DEVIATION 1.4 | 6.6 ribs STANDARD_DEVIATION 3.7 | 4.7 ribs STANDARD_DEVIATION 2.5 |
| Region of Enrollment United States | 10 participants | 2 participants | 5 participants | 3 participants |
| Sex: Female, Male Female | 6 Participants | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 3 | 2 / 5 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 | 0 / 1 |
Outcome results
Primary
Narcotic Use
Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours.
Time frame: 3 days or hospital length of stay, if less than 3 days
Population: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCA Only | Narcotic Use | 3.7 mg/24 hours over days 1-3 | Standard Deviation 3.5 |
| Bupivicaine 0.25% (LOW DOSE) | Narcotic Use | 8.2 mg/24 hours over days 1-3 | Standard Deviation 5.16 |
| Bupivicaine 0.5% (HIGH DOSE) | Narcotic Use | 2.5 mg/24 hours over days 1-3 | Standard Deviation 0 |
Secondary
Hospital Length of Stay
Integer days of inpatient admission in the hospital stay that included randomization.
Time frame: from randomization to discharge, usually within the range of 5-15 days
Population: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one subject to analyze, so standard deviation =0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCA Only | Hospital Length of Stay | 5.0 days | Standard Deviation 2.1 |
| Bupivicaine 0.25% (LOW DOSE) | Hospital Length of Stay | 11.1 days | Standard Deviation 8.6 |
| Bupivicaine 0.5% (HIGH DOSE) | Hospital Length of Stay | 3.6 days | Standard Deviation 0 |
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.
Time frame: 3 days or hospital length of stay, whichever is longer
Population: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCA Only | Morbidity | 0 number of complications |
| Bupivicaine 0.25% (LOW DOSE) | Morbidity | 0 number of complications |
| Bupivicaine 0.5% (HIGH DOSE) | Morbidity | 0 number of complications |
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.
Time frame: 30 days
Population: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PCA Only | Mortality | 0 Participants |
| Bupivicaine 0.25% (LOW DOSE) | Mortality | 0 Participants |
| Bupivicaine 0.5% (HIGH DOSE) | Mortality | 0 Participants |
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.
Time frame: from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit
Population: Only patients analyzed who had surgical intensive care unit admission.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCA Only | Surgical Intensive Care Unit (SICU) Length of Stay | 2.3 days | Standard Deviation 0 |
| Bupivicaine 0.25% (LOW DOSE) | Surgical Intensive Care Unit (SICU) Length of Stay | 5.1 days | Standard Deviation 3.4 |
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.
Time frame: 3 days or hospital length of stay, if less than 3 days
Population: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. Only one subject remains to be analyzed in that group so standard deviation = 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCA Only | Time to Improvement in Pain Intensity | 2.0 days | Standard Deviation 0 |
| Bupivicaine 0.25% (LOW DOSE) | Time to Improvement in Pain Intensity | 3.0 days | Standard Deviation 0 |
| Bupivicaine 0.5% (HIGH DOSE) | Time to Improvement in Pain Intensity | 1.0 days | Standard Deviation 0 |
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).
Time frame: 3 days or hospital length of stay, if less than 3 days
Population: One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one member to analyze; therefore standard deviation = 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PCA Only | Time to Improvement in Pulmonary Function | 1.7 days | Standard Deviation 1.5 |
| Bupivicaine 0.25% (LOW DOSE) | Time to Improvement in Pulmonary Function | 1.8 days | Standard Deviation 1.6 |
| Bupivicaine 0.5% (HIGH DOSE) | Time to Improvement in Pulmonary Function | 1.0 days | Standard Deviation 0 |