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NCT03823534RecruitingPhase 3

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Source: ClinicalTrials.gov · Last updated 22 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
60 (estimated)
First submitted
22 Jan 2019
Start date
20 Feb 2019
Primary completion date
31 Dec 2026
Lead sponsor
St. Louis University
NCT number
NCT03823534

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 60
  • From 20 Feb 2019 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent pathologic fracture
  • Concurrent chemotherapy regimen that prevents NSAID use
  • Current use of the medication probenecid
  • Current use of the medication Pentoxifylline

Other illness

  • History of Peptic Ulcer Disease with bleeding or requiring hospitalization
  • History of NSAID or aspirin allergy
  • History of liver disease that precludes use of toradol
  • History of heart failure or cardiovascular disease that precludes toradol usage
  • History of narcotic allergy resulting in anaphylaxis
  • Patients with acetaminophen allergies resulting in anaphylaxis
  • History of aspirin induced asthma.
  • Known history of opioid dependence, abuse, or addiction.

Lab values

  • History of advanced renal impairment (eGFR\<30mL/min)
  • Patients with coagulation disorders or those who require concomitant use of anticoagulant or anti- platelet therapy during the treatment phase of the study.

Other

  • Pregnancy
  • Bilateral IMN of the femurs

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Saint Louis University
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.