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Post-Op Pain Control for Prophylactic Intramedullary Nailing.


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. 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.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 o

Trial 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 Info

Organization

St. Louis University


Primary Outcome

Milligram Morphine Equivalent (MME) of Opioid Medications Utilized


Outcome Timeframe Post-op days 1-14

NCTID NCT03823534

Phases PHASE3

Primary Purpose TREATMENT

Start Date 2019-02-20

Completion Date 2024-08-01

Enrollment Target 60

Interventions

DRUG Ketorolac

DRUG Normal saline

DRUG Acetaminophen

DRUG Oxycodone Acetaminophen

DRUG Morphine

DRUG Hydrocodone/Acetaminophen

DRUG Oxycodone

Locations Recruiting

Saint Louis University

United States, Missouri, Saint Louis


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