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Lack of personnel and lack of funding for the study drug
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator | Placebo Comparator | Participants will receive placebo infusion consisting of normal saline |
|
| Active Comparator | Active Comparator | Participants will receive a lidocaine infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline infusion | Drug | Normal saline infusion at 10mL/hour |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours | MME = morphine milligram equivalent | After 24 hours of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 48 Hrs | After 48 hours of treatment | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Healthcare | Stanford | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10969322 | Background | Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available. | |
| 16269301 | Background | Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Comparator | Participants will receive placebo infusion consisting of normal saline. |
| FG001 | Active Comparator | Participants will receive a lidocaine infusion at 1.0mg/kg/hr. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator | Participants will receive a lidocaine infusion at 1.0mg/kg/hr. |
| 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 | Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours | MME = morphine milligram equivalent | Posted | Mean | Standard Deviation | MME | After 24 hours of treatment |
|
|
29 hours
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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 | Active Comparator | Participants will receive a lidocaine infusion at 1.0mg/kg/hr. |
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This study did not meet its planned enrollment size and did not achieve statistical significance as prespecified in the study protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chi-Ho Ban Tsui | Stanford University | (650) 200-9107 | bantsui@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2019 | Sep 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
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| Lidocaine infusion |
| Drug |
Lidocaine infusion at 1.0mg/kg/hr |
|
| Baseline and 1, 10, 13, 16, and 17 hours post-lidocaine infusion |
| Incentive Spirometry Volumes | An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale. | Pre-infusion baseline and 24 hours post-infusion |
| 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 0, 24 hours, 48 hour, and 72 hours. |
| Length of Hospital Stay | Number of hours stayed at the hospital from the day of operation till the day of discharge. | 29 hours |
| Inflammatory Biomarkers | Proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10) | Time 0, 24 hours, and 48 hour |
| Number of Pulmonary Complication Events | Pulmonary complications include ARDS, pneumonia, aspiration, empyema, etc. | 29 hours |
| 24612969 | Background | Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31. |
| 21256488 | Background | Battle CE, Hutchings H, Evans PA. Risk factors that predict mortality in patients with blunt chest wall trauma: a systematic review and meta-analysis. Injury. 2012 Jan;43(1):8-17. doi: 10.1016/j.injury.2011.01.004. Epub 2011 Jan 22. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
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| Secondary | Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 48 Hrs | No data were collected for this outcome, patient was discharged prior to this time point. | Posted | After 48 hours of treatment |
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1, 10, 13, 16, and 17 hours post-lidocaine infusion |
|
|
|
| Secondary | Incentive Spirometry Volumes | An incentive spirometer is a device that measures how deeply you can inhale. Higher volumes indicate greater ability to inhale. | Standard deviation not calculable for n of 1 | Posted | Mean | Standard Deviation | mL | Pre-infusion baseline and 24 hours post-infusion |
|
|
|
| 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. | Data were not collected for this outcome measure. | Posted | Time 0, 24 hours, 48 hour, and 72 hours. |
|
|
| Secondary | Length of Hospital Stay | Number of hours stayed at the hospital from the day of operation till the day of discharge. | Posted | Mean | Standard Deviation | hours | 29 hours |
|
|
|
| Secondary | Inflammatory Biomarkers | Proinflammatory markers (IL6, IL8, IL-1β, TNF-α) and f anti-inflammatory markers (IL10) | Data were not collected for this outcome measure. | Posted | Time 0, 24 hours, and 48 hour |
|
|
| Secondary | Number of Pulmonary Complication Events | Pulmonary complications include ARDS, pneumonia, aspiration, empyema, etc. | Posted | Mean | Standard Deviation | events | 29 hours |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| Measurements |
|---|
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| 13 hours post-infusion |
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| 16 hours post-infusion |
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| 17 hours post-infusion |
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