Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Bone Metastases, Lymphoma, Multiple Myeloma, Opioid Use, Pain

In brief

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 because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.

Key facts

Study ID

NCT03823534

Run by

St. Louis University

People needed

60

Starts

2019-02-20

Expected to finish

2027-03-31

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Saint Louis University — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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