Status:

RECRUITING

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Lead Sponsor:

St. Louis University

Conditions:

Bone Metastases

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control becaus...

Detailed Description

Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control becaus...

Eligibility Criteria

Inclusion

  • Femoral Shaft or Neck bone lesion
  • 18 years old or greater
  • Plan to undergo prophylactic intramedullary nailing of one femur

Exclusion

  • Concurrent pathologic fracture
  • History of advanced renal impairment (eGFR\<30mL/min)
  • History of Peptic Ulcer Disease with bleeding or requiring hospitalization
  • History of NSAID or aspirin allergy
  • Concurrent chemotherapy regimen that prevents NSAID use
  • History of liver disease that precludes use of toradol
  • History of heart failure or cardiovascular disease that precludes toradol usage
  • Pregnancy
  • History of narcotic allergy resulting in anaphylaxis
  • Patients with coagulation disorders or those who require concomitant use of anticoagulant or anti- platelet therapy during the treatment phase of the study.
  • Patients with acetaminophen allergies resulting in anaphylaxis
  • Current use of the medication probenecid
  • Current use of the medication Pentoxifylline
  • History of aspirin induced asthma.
  • Known history of opioid dependence, abuse, or addiction.
  • Bilateral IMN of the femurs

Key Trial Info

Start Date :

February 20 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT03823534

Start Date

February 20 2019

End Date

December 31 2026

Last Update

October 15 2025

Active Locations (1)

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1

Saint Louis University

St Louis, Missouri, United States, 63110