NSAIDS vs Opioids in Tibial Fractures

Phase 4

Recruiting

• Conditions: Trauma
• Interventions: Drug: NSAIDs

• Registration Number: NCT05332314
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study Start: 2019-11-12
• Status Verified: 2022-04
• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-04-15
• Last Update Submitted: 2022-04-15
• Study First Posted: 2022-04-18
• Last Update Posted: 2022-04-18
• Primary Completion: 2024-01-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSAIDs	NSAIDs	This arm is given NSAIDs perioperatively and after discharge

Primary Outcome Measures

Name	Time	Method
Time to union	through study completion, an average of 1 year	The time from surgery to bone healing

Trial Locations

Locations (2)

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States