NCT05332314

NSAIDS vs Opioids in Tibial Fractures

NSAIDs and Time to Union in Diaphyseal Tibia Fractures: Do NSAIDs Make a Difference

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 105 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma

Interventions

Type	Name	Description
DRUG	NSAIDs	The patients will be given NSAIDs with a reduced dose of the standard opioids treatment.

Timeline

• Start date: 2019-11-12
• Primary completion: 2024-01-30
• Completion: 2025-05-30
• First posted: 2022-04-18
• Last updated: 2022-04-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study