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Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Recruiting
18 years and older
All
Phase 3

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Overview

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.

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 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, often due to bone metastases that increase risk for future fractures. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use.

Recent literature has demonstrated the efficacy of multi-modal pain management in treating post-op pain [1]. Currently, patients that undergo prophylactic intramedullary femur nail placement at SLU are often treated with both narcotics and toradol, as long as they can tolerate NSAIDs. However, the effect of toradol in addition to narcotics has not been determined. 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

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

Study details
    Bone Metastases
    Lymphoma
    Multiple Myeloma
    Opioid Use
    Pain

NCT03823534

St. Louis University

27 January 2024

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