Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Major Extremity Trauma Research Consortium
Study ID
NCT07006675
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Pain
  • Tibial Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 600 mg Ibuprofen — DRUG
    Treatment patients will receive oral ibuprofen 600 mg three times a day (tid) for up to six weeks. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs. For patients who have a clinical concern regarding NSAID and prophylactic anticoagulation, the treating physician may consider prescribing misoprostol.

Study Details

Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.

Key Dates

Start date
May 26, 2021
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care Pain Management with NSAIDs
    Treatment patients will receive oral ibuprofen 600 mg three times a day (tid) for up to six weeks. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs. For patients who have a clinical concern regarding NSAID and prophylactic anticoagulation, the treating physician may consider prescribing misoprostol.
  • No Intervention: Standard of Care Pain Management without NSAIDs
    Control patients will receive standard of care pain medication regimen and may not use NSAIDs. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs.

Primary Outcome Measure

Secondary surgery to promote bone union after 3 months post initial surgery [ Time Frame: 1 year ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Eskenazi HospitalIndianapolisIndiana46202
Karl Shively, MD (PRINCIPAL_INVESTIGATOR)
Indiana University-MethodistIndianapolisIndiana46202
Lauren Hill, BS
[email protected]
Brian Mullis, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland R Adams Cowley Shock Trauma CenterBaltimoreMaryland21201
Yasmin Degani
[email protected]
Robert O'Toole, MD (PRINCIPAL_INVESTIGATOR)
Harvard Medical CenterCambridgeMassachusetts02138
Michael Weaver, MD (PRINCIPAL_INVESTIGATOR)
Hennepin HealthMinneapolisMinnesota55487
Olutayo Alese
[email protected]
612-873-4634
Andrew Schmidt, MD (PRINCIPAL_INVESTIGATOR)
Nancy Luger, MD (PRINCIPAL_INVESTIGATOR)
University of MississippiJacksonMississippi39216
Patrick Bergin, MD (PRINCIPAL_INVESTIGATOR)
The MetroHealth SystemClevelandOhio44109
Nicholas Romeo, MD (PRINCIPAL_INVESTIGATOR)
Allegheny General HospitalPittsburghPennsylvania15212
Gregory Altman, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt Medical CenterNashvilleTennessee37203
Karen Trochez
[email protected]
William Obremskey, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center - HoustonHoustonTexas77030
Sterling Boutte
[email protected]
Stephen Warner, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84108
Thomas Higgins, MD (PRINCIPAL_INVESTIGATOR)
Inova Fairfax HospitalFalls ChurchVirginia22042
Greg Gaski, MD (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53705
Chris Domes, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By research site
Eskenazi Hospital· Indianapolis, INIndiana University-Methodist· Indianapolis, INUniversity of Maryland R Adams Cowley Shock Trauma Center· Baltimore, MDHarvard Medical Center· Cambridge, MAHennepin Health· Minneapolis, MNUniversity of Mississippi· Jackson, MS

Related Studies