MAST Trial: Multi-modal Analgesic Strategies in Trauma (MAST)

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].

Study Overview

• Status: Completed
• Conditions: Nonspecific Pain Post Traumatic Injury
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 1561
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Original MMPR - descending dose arm; 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; Acetaminophen 1g IV/PO every 6 hours; Drug: Acetaminophen PO; Acetaminophen 1g PO every 6 hours; Drug: Ketorolac; Ketorolac 30mg IV once; Drug: Celebrex; Celebrex 200mg PO every 12 hours; Drug: Naproxen; Naproxen 500mg PO every 12 hours; Drug: Tramadol; Tramadol 100mg PO every 6 hours; Drug: Pregabalin; Pregabalin 100mg PO every 8 hours; Drug: Gabapentin; Gabapentin 300mg PO every 8 hours; Drug: Lidocaine; Lidocaine patch every 12 hours; Drug: Opioids; Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl); Drug: Regional anesthesia; Regional anesthesia
Active Comparator: MAST MMPR - escalating dose arm; 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; Acetaminophen 1g PO every 6 hours; Drug: Ketorolac; Ketorolac 30mg IV once; Drug: Naproxen; Naproxen 500mg PO every 12 hours; Drug: Gabapentin; Gabapentin 300mg PO every 8 hours; Drug: Lidocaine; Lidocaine patch every 12 hours; Drug: Opioids; Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl); Drug: Regional anesthesia; Regional anesthesia

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: John Harvin, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Harvin JA, Green CE, Vincent LE, Motley KL, Podbielski J, Miller CC, Tyson JE, Holcomb JB, Wade CE, Kao LS. Multi-modal Analgesic Strategies for Trauma (MAST): protocol for a pragmatic randomized trial. Trauma Surg Acute Care Open. 2018 Aug 19;3(1):e000192. doi: 10.1136/tsaco-2018-000192. eCollection 2018.
• Harvin JA, Albarado R, Truong VTT, Green C, Tyson JE, Pedroza C, Wade CE, Kao LS; MAST Study Group. Multi-Modal Analgesic Strategy for Trauma: A Pragmatic Randomized Clinical Trial. J Am Coll Surg. 2021 Mar;232(3):241-251.e3. doi: 10.1016/j.jamcollsurg.2020.12.014. Epub 2021 Jan 21.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): July 3, 2019
• Study Completion (Actual): July 3, 2019

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Antimanic Agents; Calcium-Regulating Hormones and Agents; Cyclooxygenase 2 Inhibitors; Calcium Channel Blockers; Gout Suppressants; Lidocaine; Gabapentin; Ketorolac; Celecoxib; Acetaminophen; Pregabalin; Tramadol; Naproxen
• Other Study ID Numbers: HSC-MS-18-0036; KL2TR000370 (U.S. NIH Grant/Contract); UL1TR000371 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No