Comparing NSAIDs and opioids for pain management in tibial fractures
NSAIDs and Time to Union in Diaphyseal Tibia Fractures: Do NSAIDs Make a Difference
This study is trying to see if using less opioids along with anti-inflammatory medications can help people with tibial fractures heal faster and feel less pain compared to those who only use standard opioids.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 105 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Trial ID | NCT05332314 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the differences in healing time, non-union rates, and post-operative pain between patients receiving opioids and those receiving NSAIDs with a reduced dosage of opioids for pain management after tibial fractures. It will involve a prospective interventional design with two randomized parallel groups, where one group receives standard opioid care and the other receives NSAIDs along with lower opioid doses. The primary outcomes will be assessed using a visual analog scale for pain and monitoring the time to union and rates of non-union. Statistical analysis will be conducted to determine any significant differences between the two groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 105 with diaphyseal tibia fractures treated with intramedullary nails.
Not a fit: Patients with tibial fractures not treated with intramedullary nails will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies and faster recovery times for patients with tibial fractures.
How similar studies have performed: Other studies have explored pain management strategies in orthopedic trauma, but this specific comparison of NSAIDs versus opioids in tibial fractures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between the ages of 18 and 105 * Diaphyseal tibia fracture (OTA/AO 42 A, B) Exclusion Criteria: -Tibial fractures not treated with intramedullary nails
Where this trial is running
Louisville, Kentucky and 1 other locations
- University of Louisville Hospital — Louisville, Kentucky, United States (Recruiting)
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Rodolfo Zamora, MD — University of Louisville
- Study coordinator: Rodolfo Zamora
- Email: rodolfo.zamora@louisville.edu
- Phone: 5028528834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.