Recruiting

NSAIDS vs. OpioidsNSAIDS vs Opioids in Tibial Fractures

Sponsor:

University of Louisville

Code:

NCT05332314

Conditions

Trauma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NSAIDs

Study Details

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

Conditions

Trauma

Study ID

NCT05332314

Start date

Nov 12, 2019

Status verified date

Apr, 2022

Completion date

May 30, 2025

Anticipated

Primary completion date

Jan 30, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NSAIDs

This arm is given NSAIDs perioperatively and after discharge

no intervention: Opioids

This arm will be given the standard opioids treatment to control pain perioperatively and at discharge.

Interventions

NSAIDs

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

Primary outcome measure

Time to union [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Rodolfo Zamora

5028528834 rodolfo.zamora@louisville.edu

Salwa Rashid

5028526964 salwa.rashid@louisville.edu

Locations

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Rodolfo Zamora, MD

502-629-5460 razamo02@louisville.edu

Salwa M Rashid, MD,MPH

5028526964 sfrash01@louisville.edu

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40292

Contacts

Rodolfo Zamora, MD

rodolfo.zamora@louisville.edu

More Information

Sponsor

University of Louisville

Last update posted

Apr 18, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2022-04-18.