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Search / Trial NCT03823534

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Launched by ST. LOUIS UNIVERSITY · Jan 29, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Toradol Ketorolac Prophylactic Intramedullary Nail Bone Metastases Opioid Use Post Operative Pain

ClinConnect Summary

This clinical trial is researching the best way to manage pain after surgery for patients who have certain types of bone lesions. Specifically, it looks at whether using a medication called Toradol, along with traditional opioid painkillers, can provide better pain relief for patients undergoing a procedure called prophylactic intramedullary nailing of the femur. This procedure is often done to prevent future fractures in patients with bone metastases, lymphoma, or multiple myeloma. The study aims to find out if adding Toradol, which is a non-steroidal anti-inflammatory drug (NSAID), can help manage pain without delaying healing.

To participate in this trial, you need to be at least 18 years old and have a bone lesion in your femur (the thigh bone) planned for surgery. However, if you have certain health conditions or allergies, such as a history of severe kidney problems, bleeding ulcers, or heart disease, you may not be eligible. If you join the trial, you can expect to receive either the combination of Toradol and opioids or just opioids after your surgery, and researchers will monitor your pain levels and recovery. This study is important because it seeks to find safer ways to manage pain while addressing the growing concerns around opioid use and the potential for addiction.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Femoral Shaft or Neck bone lesion
  • 2. 18 years old or greater
  • 3. Plan to undergo prophylactic intramedullary nailing of one femur
  • Exclusion Criteria:
  • 1. Concurrent pathologic fracture
  • 2. History of advanced renal impairment (eGFR\<30mL/min)
  • 3. History of Peptic Ulcer Disease with bleeding or requiring hospitalization
  • 4. History of NSAID or aspirin allergy
  • 5. Concurrent chemotherapy regimen that prevents NSAID use
  • 6. History of liver disease that precludes use of toradol
  • 7. History of heart failure or cardiovascular disease that precludes toradol usage
  • 8. Pregnancy
  • 9. History of narcotic allergy resulting in anaphylaxis
  • 10. Patients with coagulation disorders or those who require concomitant use of anticoagulant or anti- platelet therapy during the treatment phase of the study.
  • 11. Patients with acetaminophen allergies resulting in anaphylaxis
  • 12. Current use of the medication probenecid
  • 13. Current use of the medication Pentoxifylline
  • 14. History of aspirin induced asthma.
  • 15. Known history of opioid dependence, abuse, or addiction.
  • 16. Bilateral IMN of the femurs

About St. Louis University

Saint Louis University (SLU) is a prestigious research institution dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong commitment to ethical research practices and collaboration across interdisciplinary teams, SLU conducts a wide range of clinical studies aimed at addressing critical health challenges. The university leverages its state-of-the-art facilities and expert faculty to facilitate groundbreaking research, ensuring that findings contribute to the development of effective therapies and enhance the overall health of diverse populations. Through its focus on community engagement and translational science, SLU fosters an environment where research translates into tangible benefits for patients and society.

Locations

Saint Louis, Missouri, United States

Patients applied

0 patients applied

Trial Officials

David Greenberg, MD

Principal Investigator

St. Louis University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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