Trauma Clinical Trial - NSAIDS vs Opioids in Tibial Fractures

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Trauma

Clinical Trial Details

NCT number	NCT05332314
Study type	Interventional
Source	University of Louisville
Contact	Rodolfo Zamora
Phone	5028528834
Email	rodolfo.zamora@louisville.edu
Status	Recruiting
Phase	Phase 4
Start date	November 12, 2019
Completion date	May 30, 2025

View Details

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