Rib Fractures
Conditions
Brief summary
The current cornerstone of pain control for rib fractures is oral and intravenous opioids, especially in the form of patient-controlled analgesia (IV PCA), which are are associated with multiple adverse effects including sedation, respiratory depression, cough suppression, and increased risk of delirium. In the past few decades, intravenous lidocaine infusion (IVL) has emerged as a new tool in the arsenal of multimodal analgesia. Multiple randomized clinical trials have indicated that IVL is overall well tolerated and have shown other beneficial effects such as anti-inflammatory properties. To this date, there have been no published randomized clinical trials (RCT) evaluating the effectiveness of IVL in management of traumatic rib fracture pain. Therefore, the purpose of this study is to evaluate whether IV Lidocaine infusion can provide improved pain control as demonstrated by decreased OME consumption at 24 and 48 hours compared to placebo in adult patients with acute traumatic rib fractures.
Interventions
DRUGSaline infusion
Normal saline infusion at 10mL/hour
DRUGLidocaine infusion
Lidocaine infusion at 1.0mg/kg/hr
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures
Exclusion criteria
* hemodynamically instability * mechanical ventilation * polytrauma (defined as bone or organ injury outside the thorax) * pregnancy * incarceration * local anesthetic allergy or contraindications to lidocaine (Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular block) * chronic opioid use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours | After 24 hours of treatment | MME = morphine milligram equivalent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Baseline and 1, 10, 13, 16, and 17 hours post-lidocaine infusion | Pain scores at rest rated using the Numeric Rating Scale (NRS) of 0-10, where 0 is no pain and 10 is the worst imaginable |
| Incentive Spirometry Volumes | Pre-infusion baseline and 24 hours post-infusion | An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale. |
| PIC Score | Time 0, 24 hours, 48 hour, and 72 hours. | PIC score is a composite score comprising pain level, ISV, and cough strength. PIC scores range from 1-10 with one being severe pain, inability to perform incentive spirometry, and absent cough and 10 being controlled pain, an incentive spirometry volume above goal volume (set by respiratory therapist), and strong cough. |
| Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 48 Hrs | After 48 hours of treatment | — |
| Inflammatory Biomarkers | Time 0, 24 hours, and 48 hour | Proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10) |
| Number of Pulmonary Complication Events | 29 hours | Pulmonary complications include ARDS, pneumonia, aspiration, empyema, etc. |
| Length of Hospital Stay | 29 hours | Number of hours stayed at the hospital from the day of operation till the day of discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator Participants will receive a lidocaine infusion at 1.0mg/kg/hr. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Active Comparator |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours
MME = morphine milligram equivalent
Time frame: After 24 hours of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator | Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours | 7.5 MME |
Secondary
Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 48 Hrs
Time frame: After 48 hours of treatment
Population: No data were collected for this outcome, patient was discharged prior to this time point.
Secondary
Incentive Spirometry Volumes
An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale.
Time frame: Pre-infusion baseline and 24 hours post-infusion
Population: Standard deviation not calculable for n of 1
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Comparator | Incentive Spirometry Volumes | Pre-infusion baseline | 1500 mL |
| Active Comparator | Incentive Spirometry Volumes | 24 hours post-infusion | 1500 mL |
Secondary
Inflammatory Biomarkers
Proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10)
Time frame: Time 0, 24 hours, and 48 hour
Population: Data were not collected for this outcome measure.
Secondary
Length of Hospital Stay
Number of hours stayed at the hospital from the day of operation till the day of discharge.
Time frame: 29 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator | Length of Hospital Stay | 29 hours |
Secondary
Number of Pulmonary Complication Events
Pulmonary complications include ARDS, pneumonia, aspiration, empyema, etc.
Time frame: 29 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator | Number of Pulmonary Complication Events | 0 events |
Secondary
Pain Score
Pain scores at rest rated using the Numeric Rating Scale (NRS) of 0-10, where 0 is no pain and 10 is the worst imaginable
Time frame: Baseline and 1, 10, 13, 16, and 17 hours post-lidocaine infusion
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Comparator | Pain Score | 1 hour post-infusion | 1 score on a scale |
| Active Comparator | Pain Score | 10 hours post-infusion | 0 score on a scale |
| Active Comparator | Pain Score | Pre-infusion baseline | 1 score on a scale |
| Active Comparator | Pain Score | 13 hours post-infusion | 0 score on a scale |
| Active Comparator | Pain Score | 16 hours post-infusion | 4 score on a scale |
| Active Comparator | Pain Score | 17 hours post-infusion | 2 score on a scale |
Secondary
PIC Score
PIC score is a composite score comprising pain level, ISV, and cough strength. PIC scores range from 1-10 with one being severe pain, inability to perform incentive spirometry, and absent cough and 10 being controlled pain, an incentive spirometry volume above goal volume (set by respiratory therapist), and strong cough.
Time frame: Time 0, 24 hours, 48 hour, and 72 hours.
Population: Data were not collected for this outcome measure.