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Post-Op Pain Control for Prophylactic Intramedullary Nailing.

RECRUITINGPhase 3Sponsored by St. Louis University
Actively Recruiting
PhasePhase 3
SponsorSt. Louis University
Started2019-02-20
Est. completion2026-10-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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 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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions6

Bone MetastasesCancerLymphomaMultiple MyelomaOpioid UsePain

Locations1 site

Saint Louis University
St Louis, Missouri, 63110
Allison Gruender, MSN314-617-3406allison.gruender@health.slu.edu

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