Actively Recruiting
Effect of NSAIDs on Union, Opioid Use, and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
Led by Major Extremity Trauma Research Consortium · Updated on 2025-06-05
1000
Participants Needed
14
Research Sites
12 weeks
Total Duration
On this page
Sponsors
M
Major Extremity Trauma Research Consortium
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of nonsteroidal anti-inflammatory drugs (NSAIDs) as part of pain management for patients with tibial shaft fractures treated with intramedullary nails. This Phase III, randomized controlled trial compares standard pain management without NSAIDs to standard pain management plus up to six weeks of NSAIDs. The study aims to determine whether adding NSAIDs affects bone healing, pain control, opioid use, side effects, and functional outcomes over one year. Participants are randomly assigned to one of two groups. The treatment group receives oral ibuprofen 600 mg three times daily for up to six weeks, with additional pain relief as needed but excluding other NSAIDs. The control group receives standard pain management without NSAIDs but may use other analgesics. Physicians may prescribe misoprostol if there are concerns about NSAID use with anticoagulation. Both groups are monitored for up to 12 months after injury. During the study, participants undergo regular assessments to measure the need for additional surgery to promote bone healing, opioid use, side effects, persistent pain, pain interference, physical and psychosocial function, and radiographic evidence of bone union. The trial includes safety monitoring and aims to collect outcomes at one year. Participants are expected to attend follow-up visits at clinical sites for evaluations and data collection throughout the study period.
CONDITIONS
Brief Title
Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with open (Grade I, II, or IIIa) or closed tibia fractures treated with a nail
- Age between 18 and 80 years inclusive
- Able to be followed at a METRC facility for at least 12 months after injury
You will not qualify if you...
- Unable to provide informed consent
- Current intravenous drug use
- History of allergy to study drugs
- Unable to swallow oral medications or lacking functioning gastrointestinal tract
- History of gastrointestinal bleeding or gastric perforation
- History of stroke or heart attack
- Require aspirin or NSAID regimen except low dose aspirin (81mg)
- Bleeding disorders
- Severe renal failure (GFR less than 30); moderate renal failure (GFR 30-59) requires dose modification
- Daily systemic glucocorticoid treatment before surgery
- Likely to have severe problems maintaining follow-up (severe psychiatric conditions, living far away, incarceration, unstable housing)
- Glasgow Coma Scale less than 15 at discharge
- Closed head injury precluding NSAID use
- Pregnant or lactating at screening
- Planned bone graft procedure at time of initial fixation surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive standard pain management with or without NSAIDs for their tibia fractures. Those in the treatment group take ibuprofen 600 mg three times a day for up to six weeks while the control group receives pain management without NSAIDs.
Weekly visits for up to 6 weeks
Duration - Up to 1 year
Participants are monitored for surgery for nonunion, opioid use, pain levels, side effects, and bone healing for up to one year after treatment.
Periodic visits over 1 year
Trial Site Locations
Total: 14 locations
1
Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
Indiana University-Methodist
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
Harvard Medical Center
Cambridge, Massachusetts, United States, 02138
Actively Recruiting
5
Hennepin Health
Minneapolis, Minnesota, United States, 55487
Actively Recruiting
6
University of Mississippi
Jackson, Mississippi, United States, 39216
Actively Recruiting
7
The MetroHealth System
Cleveland, Ohio, United States, 44109
Actively Recruiting
8
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
9
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
University of Texas Health Science Center - Houston
Houston, Texas, United States, 77030
Actively Recruiting
11
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
12
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
13
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
14
University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada
Actively Recruiting
Research Team
T
Thomas Higgins, MD
K
Katherine Frey, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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