Ibuprofen for Tibia Fractures and Pain Management
This study is looking at how ibuprofen affects healing and pain for people with tibia (shin bone) fractures. It's comparing two groups: one receiving standard pain management without NSAIDs (non-steroidal anti-inflammatory drugs) and another receiving standard pain management plus 600 mg of ibuprofen three times a day for up to six weeks. The researchers want to see if ibuprofen can improve pain control and reduce the need for opioids without causing more complications, like needing another surgery to help the bone heal. You might be able to join if you are 18-80 years old, have an open or closed tibia fracture treated with a nail, and can be followed for at least 12 months. The study is currently recruiting 1000 participants.
- Study design
- This is a pragmatic, randomized controlled multicenter study (Phase III) with two groups, aiming to enroll 1000 participants.
- What's involved
- Participants would receive either standard pain management or standard pain management plus ibuprofen for up to six weeks. You would be followed at a METRC facility for at least 12 months after your injury.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 12 months after their injury, with the primary outcome measured at 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
At a glance
Conditions
Where it's being run
14 sites across 13 statesStudy leadership
- Thomas Higgins, MD · PRINCIPAL_INVESTIGATOR · University of Utah
- Renan Castillo, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Secondary surgery to promote bone union after 3 months post initial surgery1 year
Bone nonunion will be assessed by the presence of a secondary surgery to promote union after 3 months and up to 12 months post definitive fixation surgery. Non-prophylactic secondary surgery to promote union will be considered evidence of nonunion. Each case will be independently reviewed by members of the METRC Central Adjudication Committee and if at least 2 members agree with the assessment of secondary surgery to promote union, no further review will be necessary. The METRC Central Adjudication Committee will convene to discuss the cases for which there is disagreement regarding non-union assessment.