Clinical trial NCT03472469: MAST Trial: Multi-modal Analgesic Strategies in Trauma
Official title: MAST Trial: Multi-modal Analgesic Strategies in Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nonspecific Pain Post Traumatic Injury
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-03-21
Enrollment: 1561
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[original multimodal pain regimen (MMPR) compared to multi-modal analgesic strategies for trauma (MAST) MMPR\].


Eligibility 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)

Primary outcomes:
measure: Opioid Use Per Day
timeFrame: until discharge from hospital or 30 days post admission (whichever is sooner)
Secondary outcomes:
measure: Pain as Assessed by Score on the Numeric Rating Scale (NRS)
timeFrame: until discharge from hospital or 30 days post admission (whichever is sooner)
measure: Pain as Assessed by Score on the Behavioral Pain Scale (BPS)
timeFrame: until discharge from hospital or 30 days post admission (whichever is sooner)
measure: Number of Participants Discharged From the Hospital With an Opioid Prescription
timeFrame: Up to 30 days
measure: Number of Participants With Any Opioid-related Complications
timeFrame: until discharge from hospital or 30 days post admission (whichever is sooner)
measure: Overall Costs
timeFrame: until discharge from hospital or 30 days post admission (whichever is sooner)
measure: Pharmacy Costs
timeFrame: until discharge from hospital or 30 days post admission (whichever is sooner)
measure: Number of Ventilator Days
timeFrame: 30 days
measure: Number of Hospital Days
timeFrame: 30 days
measure: Number of Intensive Care Unti (ICU) Days
timeFrame: 30 days
measure: 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)
timeFrame: until discharge from hospital or 30 days post admission (whichever is sooner)
measure: Degree to Which Function is Limited by Pain as Indicated by Number of Participants Who Failed to Work With Physical Therapist Due to Pain
timeFrame: until discharge from hospital or 30 days post admission (whichever is sooner)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: John Harvin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.