RECRUITING

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

Conditions

Tibial Fractures Pain Ibuprofen Pain Management Tibia Fracture IM Nail Fixation NSAID

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.

Official Title

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

Quick Facts

Study Start:2021-05-26

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07006675

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail. 2. Patients 18-80 years old inclusive. 3. Patients able to be followed at a METRC facility for at least 12 months following injury	1. Patient unable to provide informed consent 2. Patients who are current - intravenous drug user. 3. Patients with a history of allergy to the study drugs. 4. Patients unable to swallow oral medications or without functioning GI tract. 5. Patients with a history of gastrointestinal bleeds or gastric perforation. 6. Patients with a history of stroke or heart attack. 7. Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg. 8. Patients with any bleeding disorders. 9. Patients with severe renal failure \[GFR:\<30\]. Patients with moderate renal failure \[GFR: 30-59\] may participate in the study at a modified dose \[see section 8.6 for defined modified dose\]. 10. Patients undergoing daily treatment with systemic glucocorticoids before surgery. 11. Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations. 12. Patients with a GCS \<15 at discharge. 13. Patients with a closed head injury that precludes NSAIDS. 14. Patients who are pregnant or lactating at time of screening 15. Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.

Inclusion Criteria

Exclusion Criteria

1. All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.
2. Patients 18-80 years old inclusive.
3. Patients able to be followed at a METRC facility for at least 12 months following injury

1. Patient unable to provide informed consent
2. Patients who are current - intravenous drug user.
3. Patients with a history of allergy to the study drugs.
4. Patients unable to swallow oral medications or without functioning GI tract.
5. Patients with a history of gastrointestinal bleeds or gastric perforation.
6. Patients with a history of stroke or heart attack.
7. Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.
8. Patients with any bleeding disorders.
9. Patients with severe renal failure \[GFR:\<30\]. Patients with moderate renal failure \[GFR: 30-59\] may participate in the study at a modified dose \[see section 8.6 for defined modified dose\].
10. Patients undergoing daily treatment with systemic glucocorticoids before surgery.
11. Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.
12. Patients with a GCS \<15 at discharge.
13. Patients with a closed head injury that precludes NSAIDS.
14. Patients who are pregnant or lactating at time of screening
15. Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.

Contacts and Locations

Study Contact

Thomas Higgins, MD

CONTACT

801-870-113

thomas.higgins@hsc.utah.edu

Katherine Frey, PhD

CONTACT

kparris1@jhu.edu

Principal Investigator

Thomas Higgins, MD

PRINCIPAL_INVESTIGATOR

University of Utah

Renan Castillo, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Eskenazi Hospital

Indianapolis, Indiana, 46202

United States

Indiana University-Methodist

Indianapolis, Indiana, 46202

United States

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201

United States

Harvard Medical Center

Cambridge, Massachusetts, 02138

United States

Hennepin Health

Minneapolis, Minnesota, 55487

United States

University of Mississippi

Jackson, Mississippi, 39216

United States

The MetroHealth System

Cleveland, Ohio, 44109

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

United States

Vanderbilt Medical Center

Nashville, Tennessee, 37203

United States

University of Texas Health Science Center - Houston

Houston, Texas, 77030

United States

University of Utah

Salt Lake City, Utah, 84108

United States

Inova Fairfax Hospital

Falls Church, Virginia, 22042

United States

University of Wisconsin

Madison, Wisconsin, 53705

United States

Collaborators and Investigators

Sponsor: Major Extremity Trauma Research Consortium

Thomas Higgins, MD, PRINCIPAL_INVESTIGATOR, University of Utah
Renan Castillo, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-26

Study Completion Date2027-03

Study Record Updates

Study Start Date2021-05-26

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

Ibuprofen
Pain Management
Tibia Fracture
IM Nail Fixation
NSAID

Additional Relevant MeSH Terms

Tibial Fractures
Pain