MAST Trial: Multi-modal Analgesic Strategies in Trauma

Study Overview
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Brief Summary
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This is a comparative effectiveness study of current pain management strategies in acutely injured trauma patients. Two different multi-modal, opioid minimizing analgesic strategies will be compared [original multimodal pain regimen (MMPR) compared to multi-modal analgesic strategies for trauma (MAST) MMPR].

Official Title
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MAST Trial: Multi-modal Analgesic Strategies in Trauma

Conditions
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Nonspecific Pain Post Traumatic Injury

Intervention / Treatment
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* Drug: Acetaminophen IV/PO
* Drug: Acetaminophen PO
* Drug: Ketorolac
* Drug: Celebrex
* Drug: Naproxen
* Drug: Tramadol
* Drug: Pregabalin
* Drug: Gabapentin
* Drug: Lidocaine
* Drug: Opioids
* Drug: Regional anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted to the trauma service who are 16 years and older. Exclusion Criteria: pregnant prisoner patients placed in observation (i.e. not admitted to the hospital)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Original MMPR - descending dose arm<br>Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g intravenously (IV)/per oral (PO) q6 hours in the first 48 hours, and Acetaminophen 1g PO q6 hours thereafter; 2. Ketorolac 30mg IV once and Celebrex 200mg PO q12 hours in the first 48 hours, and Naproxen 500mg PO q12 hours thereafter; 3. Tramadol 100mg PO q6 hours in the first 48 hours, and Tramadol 100mg PO q6 hours thereafter; 4. Pregabalin 100mg PO q8 hours in the first 48 hours, and Gabapentin 300mg PO q8 hours thereafter; 5. Lidocaine patch q12 hours in the first 48 hours, and Lidocaine patch q12 hours thereafter; and 6. Opioids (Regional anesthesia) in the first 48 hours, and Opioids and Regional anesthesia thereafter. | Drug: Acetaminophen IV/PO<br>* Acetaminophen 1g IV/PO every 6 hours<br>Drug: Acetaminophen PO<br>* Acetaminophen 1g PO every 6 hours<br>Drug: Ketorolac<br>* Ketorolac 30mg IV once<br>Drug: Celebrex<br>* Celebrex 200mg PO every 12 hours<br>Drug: Naproxen<br>* Naproxen 500mg PO every 12 hours<br>Drug: Tramadol<br>* Tramadol 100mg PO every 6 hours<br>Drug: Pregabalin<br>* Pregabalin 100mg PO every 8 hours<br>Drug: Gabapentin<br>* Gabapentin 300mg PO every 8 hours<br>Drug: Lidocaine<br>* Lidocaine patch every 12 hours<br>Drug: Opioids<br>* Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)<br>Drug: Regional anesthesia<br>* Regional anesthesia<br>|
| Active Comparator: MAST MMPR - escalating dose arm<br>Drugs are scheduled around the clock as follows: 1. Acetaminophen 1g PO q6 hours at admission and thereafter; 2. Ketorolac 30mg IV once and Naproxen 500mg PO q12 hours at admission and thereafter; 3. No drug; 4; Gabapentin 300mg PO q8 hours at admission and thereafter; 5. Lidocaine patch q12 hours at admission and thereafter; and 6. Tramadol and Opioids and Regional anesthesia at admission and thereafter. | Drug: Acetaminophen PO<br>* Acetaminophen 1g PO every 6 hours<br>Drug: Ketorolac<br>* Ketorolac 30mg IV once<br>Drug: Naproxen<br>* Naproxen 500mg PO every 12 hours<br>Drug: Gabapentin<br>* Gabapentin 300mg PO every 8 hours<br>Drug: Lidocaine<br>* Lidocaine patch every 12 hours<br>Drug: Opioids<br>* Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)<br>Drug: Regional anesthesia<br>* Regional anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use Per Day | Opioid use per day is calculated by tallying the dose equivalency of all opioids received and dividing by the number of days hospitalized. Morphine milligram equivalents (MME) per day are reported. | until discharge from hospital or 30 days post admission (whichever is sooner) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as Assessed by Score on the Numeric Rating Scale (NRS) | An average will be calculated of the daily numeric rating scale (NRS) for pain (0=no pain, 10=worst pain). This assessment is used in verbal participants. | until discharge from hospital or 30 days post admission (whichever is sooner) | 
| Pain as Assessed by Score on the Behavioral Pain Scale (BPS) | An average will be calculated of the daily score on the Behavioral Pain Scale (BPS). BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants. | until discharge from hospital or 30 days post admission (whichever is sooner) | 
| Number of Participants Discharged From the Hospital With an Opioid Prescription |  | Up to 30 days | 
| Number of Participants With Any Opioid-related Complications | Opioid-related complications include ileus, aspiration, unplanned intubation, unplanned admission to an intensive care unit, and use of an opioid-reversal agent. | until discharge from hospital or 30 days post admission (whichever is sooner) | 
| Overall Costs | the costs associated with the overall hospitalization or the first 30 days (whichever is sooner) related to post trauma care and complications incurred. | until discharge from hospital or 30 days post admission (whichever is sooner) | 
| Pharmacy Costs | The costs of the pain medications given during the specified time period. | until discharge from hospital or 30 days post admission (whichever is sooner) | 
| Number of Ventilator Days | The number of days the patient on a ventilator post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval. | 30 days | 
| Number of Hospital Days | The number of days the patient was hospitalized post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval. | 30 days | 
| Number of Intensive Care Unti (ICU) Days | The number of days the patient was in the ICU post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval. | 30 days | 
| Degree to Which Function is Limited by Pain as Assessed by Percent of Predicted Daily Incentive Spirometry Volumes (Which is Based on Ideal Body Weight) | Clinical based pain scores ranging from 0 to 10 will be assessed at regular intervals throughout the hospitalization. | until discharge from hospital or 30 days post admission (whichever is sooner) | 
| Degree to Which Function is Limited by Pain as Indicated by Number of Participants Who Failed to Work With Physical Therapist Due to Pain |  | until discharge from hospital or 30 days post admission (whichever is sooner) |