Blunt Chest Wall Trauma, Rib Fracture, Sternal Fracture
Conditions
Brief summary
This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall trauma.
Detailed description
The purpose of this study is to evaluate the efficacy of liposomal bupivacaine to provide analgesia via paravertebral intercostal nerve block following significant blunt chest trauma, minimizing adverse outcomes, length of stay and overall narcotic use. The primary outcome of the study is to compare requirements between the bupivacaine group and a standard-of-care group.
Interventions
DRUGLiposomal bupivacaine
1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
DRUG0.9% sodium chloride
1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Sponsors
United States Air Force
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Anticipated length of stay of at least 72 hours * Blunt chest wall trauma with two or more rib or sternal fractures * Demonstrated ability to achieve \> 50% predicted inspiratory capacity based on ideal body weight using IS within the first 24 hours of admission
Exclusion criteria
* Known allergy to bupivacaine * Respiratory failure requiring intubation within 24 hours prior to enrollment * Known or suspected atrioventricular nodal blockade process requiring cardiology evaluation or pacemaker placement * Hemodynamic instability (defined as new intravenous vasopressor or inotrope requirement or mean arterial pressure \< 55 mmHg) * Signs of active myocardial ischemia or non-ST elevation MI * \> 20 rib fractures * Weight \< 50 kg or \> 150 kg * Pregnancy * Incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Requirement at 24 Hours Post-randomization | 24 hours following randomization. | Opioid requirement (in morphine equivalents) at 24 hours post-randomization |
| Opioid Requirement at 48 Hours Post-randomization. | 48 hours following randomization. | Opioid requirement (in morphine equivalents) at 48 hours post-randomization |
| Opioid Requirement at 72 Hours Post-randomization | 72 hours following randomization. | Opioid requirement (in morphine equivalents) at 72 hours post-randomization |
| Opioid Requirement at 96 Hours Post-randomization | 96 hours following randomization. | Opioid requirement (in morphine equivalents) at 96 hours post-randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of Pneumonia | 96 hours following randomization | Development of pneumonia defined as \>100,000 colony forming units/milliliter bacteria on bronchoalveolar lavage or clinically with leukocytosis, pulmonary infiltrate and fever with 96 hours post-randomization. |
| Self-reported Pain at 96 Hours Post-randomization | At 96 hours post-randomization | Self-reported pain will be measured using the verbal NRS, a 0-10 ordinal scale. Pain assessments will be reported at 96 hours after enrollment, as this is the reported duration of effect for liposomal bupivacaine. Higher scores (10) indicate more pain, lower scores (0) indicate lower pain. |
Countries
United States
Participant flow
Pre-assignment details
To achieve an 80% power with an alpha of 0.05, the goal enrollment was 200 patients. Interim analyses were performed after 50 patients further providing evidence to support the 200 patient goal for enrollment. Due to changes in analgesia protocols away from epidural catheters and a change in exclusion criteria to include those who were candidates for surgical stabilization of rib fractures, as well as the COVID-19 pandemic, enrollment was stopped at 100 patients
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position | 50 |
| 0.9% Sodium Chloride 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine | 0.9% Sodium Chloride | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 18 | 61 years STANDARD_DEVIATION 18 | 60 years STANDARD_DEVIATION 18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 50 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Incentive spirometry | 17.8 Liters/min STANDARD_DEVIATION 8.1 | 17.6 Liters/min STANDARD_DEVIATION 6.6 | 17.7 Liters/min STANDARD_DEVIATION 7.39 |
| Sex: Female, Male Female | 25 Participants | 22 Participants | 47 Participants |
| Sex: Female, Male Male | 25 Participants | 28 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 4 / 50 | 2 / 50 |
Outcome results
Primary
Opioid Requirement at 24 Hours Post-randomization
Opioid requirement (in morphine equivalents) at 24 hours post-randomization
Time frame: 24 hours following randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Opioid Requirement at 24 Hours Post-randomization | 38 morphine milligram equivalents | Standard Deviation 959 |
| 0.9% Sodium Chloride | Opioid Requirement at 24 Hours Post-randomization | 202 morphine milligram equivalents | Standard Deviation 691 |
Primary
Opioid Requirement at 48 Hours Post-randomization.
Opioid requirement (in morphine equivalents) at 48 hours post-randomization
Time frame: 48 hours following randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Opioid Requirement at 48 Hours Post-randomization. | 298 morphine milligram equivalents | Standard Deviation 1036 |
| 0.9% Sodium Chloride | Opioid Requirement at 48 Hours Post-randomization. | 82 morphine milligram equivalents | Standard Deviation 129 |
Primary
Opioid Requirement at 72 Hours Post-randomization
Opioid requirement (in morphine equivalents) at 72 hours post-randomization
Time frame: 72 hours following randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Opioid Requirement at 72 Hours Post-randomization | 413 morphine milligram equivalents | Standard Deviation 1714 |
| 0.9% Sodium Chloride | Opioid Requirement at 72 Hours Post-randomization | 116 morphine milligram equivalents | Standard Deviation 199 |
Primary
Opioid Requirement at 96 Hours Post-randomization
Opioid requirement (in morphine equivalents) at 96 hours post-randomization
Time frame: 96 hours following randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Opioid Requirement at 96 Hours Post-randomization | 637 morphine milligram equivalents | Standard Deviation 2012 |
| 0.9% Sodium Chloride | Opioid Requirement at 96 Hours Post-randomization | 39 morphine milligram equivalents | Standard Deviation 56 |
Secondary
Development of Pneumonia
Development of pneumonia defined as \>100,000 colony forming units/milliliter bacteria on bronchoalveolar lavage or clinically with leukocytosis, pulmonary infiltrate and fever with 96 hours post-randomization.
Time frame: 96 hours following randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine | Development of Pneumonia | 3 Participants |
| 0.9% Sodium Chloride | Development of Pneumonia | 1 Participants |
Secondary
Self-reported Pain at 96 Hours Post-randomization
Self-reported pain will be measured using the verbal NRS, a 0-10 ordinal scale. Pain assessments will be reported at 96 hours after enrollment, as this is the reported duration of effect for liposomal bupivacaine. Higher scores (10) indicate more pain, lower scores (0) indicate lower pain.
Time frame: At 96 hours post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Self-reported Pain at 96 Hours Post-randomization | 6.32 score on a scale | Standard Deviation 2.73 |
| 0.9% Sodium Chloride | Self-reported Pain at 96 Hours Post-randomization | 6.44 score on a scale | Standard Deviation 2.93 |