Status:
RECRUITING
Post-Op Pain Control for Prophylactic Intramedullary Nailing.
Lead Sponsor:
St. Louis University
Conditions:
Bone Metastases
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 becaus...
Detailed 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 becaus...
Eligibility Criteria
Inclusion
- Femoral Shaft or Neck bone lesion
- 18 years old or greater
- Plan to undergo prophylactic intramedullary nailing of one femur
Exclusion
- 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
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03823534
Start Date
February 20 2019
End Date
December 31 2026
Last Update
October 15 2025
Active Locations (1)
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1
Saint Louis University
St Louis, Missouri, United States, 63110