Trauma
Conditions
Brief summary
This study will attempt to determine if there is a statistic difference between the time to union, non-union rate and post-operative pain of patients who receive opioids for pain control vs. patients who receive NSAIDs and a reduced dosage of opioids for pain management
Detailed description
The study will be a prospective interventional study with two randomized parallel groups. Randomization will take place immediately following the identification of a potential participant. The control group will receive the standard of care for diaphyseal tibia fractures. The standard of care consists of intramedullary nailing and post-operative opioids for pain control. The interventional group will have the same surgical indication and intervention but will differ in the primary method of pain control. The study group will receive NSAIDs and a reduced dosage of opioids for pain control. Primary outcome measures will be time to union, non-union, and pain over the post-operative period measured by a VAS pain scale. Once the data collection of both groups is complete, the statistical analysis will begin to determine if there is a statistical difference between the control and study groups in the primary outcome measurements.
Interventions
DRUGNSAIDs
The patients will be given NSAIDs with a reduced dose of the standard opioids treatment.
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will be a prospective interventional study with two randomized parallel groups. Randomization will take place immediately following the identification of a potential participant. The control group will receive the standard of care for diaphyseal tibia fractures. The standard of care consists of intramedullary nailing and post-operative opioids for pain control. The interventional group will have the same surgical indication and intervention but will differ in the primary method of pain control. The study group will receive NSAIDs and a reduced dosage of opioids for pain control. Primary outcome measures will be time to union, non-union, and pain over the post-operative period measured by a VAS pain scale. Once the data collection of both groups is complete, the statistical analysis will begin to determine if there is a statistical difference between the control and study groups in the primary outcome measurements
Eligibility
Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to union | through study completion, an average of 1 year | The time from surgery to bone healing |
Countries
United States
Contacts
Primary ContactRodolfo Zamora
Backup ContactSalwa Rashid
Outcome results
None listed