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

• ClinicalTrials.gov Identifier: NCT03472469
• Recruitment Status: Completed
• First Posted: March 21, 2018
• Results First Posted: June 10, 2021
• Last Update Posted: June 18, 2021
• Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: National Center for Advancing Translational Science (NCATS)
• Information provided by (Responsible Party): John Andrew Harvin, The University of Texas Health Science Center, Houston

Study Description

Brief Summary:

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].

Condition or disease	Intervention/treatment	Phase
Nonspecific Pain Post Traumatic Injury	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	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1561 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MAST Trial: Multi-modal Analgesic Strategies in Trauma
• Actual Study Start Date: April 2, 2018
• Actual Primary Completion Date: July 3, 2019
• Actual Study Completion Date: July 3, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Opioid Use Per Day [ Time Frame: until discharge from hospital or 30 days post admission (whichever is sooner) ]
   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.

Secondary Outcome Measures :

1. Pain as Assessed by Score on the Numeric Rating Scale (NRS) [ Time Frame: until discharge from hospital or 30 days post admission (whichever is sooner) ]
   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.
2. Pain as Assessed by Score on the Behavioral Pain Scale (BPS) [ Time Frame: until discharge from hospital or 30 days post admission (whichever is sooner) ]
   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.
3. Number of Participants Discharged From the Hospital With an Opioid Prescription [ Time Frame: Up to 30 days ]
4. Number of Participants With Any Opioid-related Complications [ Time Frame: until discharge from hospital or 30 days post admission (whichever is sooner) ]
   Opioid-related complications include ileus, aspiration, unplanned intubation, unplanned admission to an intensive care unit, and use of an opioid-reversal agent.
5. Overall Costs [ Time Frame: until discharge from hospital or 30 days post admission (whichever is sooner) ]
   the costs associated with the overall hospitalization or the first 30 days (whichever is sooner) related to post trauma care and complications incurred.
6. Pharmacy Costs [ Time Frame: until discharge from hospital or 30 days post admission (whichever is sooner) ]
   The costs of the pain medications given during the specified time period.
7. Number of Ventilator Days [ Time Frame: 30 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."
8. Number of Hospital Days [ Time Frame: 30 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."
9. Number of Intensive Care Unti (ICU) Days [ Time Frame: 30 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."
10. 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) [ Time Frame: until discharge from hospital or 30 days post admission (whichever is sooner) ]
    Clinical based pain scores ranging from 0 to 10 will be assessed at regular intervals throughout the hospitalization.
11. Degree to Which Function is Limited by Pain as Indicated by Number of Participants Who Failed to Work With Physical Therapist Due to Pain [ Time Frame: until discharge from hospital or 30 days post admission (whichever is sooner) ]

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

National Center for Advancing Translational Science (NCATS)

Investigators

• Principal Investigator: John Harvin, MD; The University of Texas Health Science Center, Houston

  Study Documents (Full-Text)

Documents provided by John Andrew Harvin, The University of Texas Health Science Center, Houston:

Study Protocol and Statistical Analysis Plan  [PDF] March 2, 2018

More Information

Publications of Results:

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.

Other 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.

• Responsible Party: John Andrew Harvin, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03472469
• Other Study ID Numbers: HSC-MS-18-0036; KL2TR000370 ( U.S. NIH Grant/Contract ); UL1TR000371 ( U.S. NIH Grant/Contract )
• First Posted: March 21, 2018
• Results First Posted: June 10, 2021
• Last Update Posted: June 18, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Wounds and Injuries; Acetaminophen; Ketorolac; Naproxen; Celecoxib; Lidocaine; Pregabalin; Gabapentin; Tramadol; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anticonvulsants; Calcium Channel Blockers; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Excitatory Amino Acid Antagonists