NCT03823534 Post-Op Pain Control for Prophylactic Intramedullary Nailing.
| NCT ID | NCT03823534 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | St. Louis University |
| Condition | Bone Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-02-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2019-02-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
David Greenberg, MD
PRINCIPAL INVESTIGATOR
St. Louis University
Frequently Asked Questions
Who can join the NCT03823534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03823534 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT03823534 currently recruiting?
Yes, NCT03823534 is actively recruiting participants. Contact the research team at david.greenberg@health.slu.edu for enrollment information.
Where is the NCT03823534 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT03823534 clinical trial?
NCT03823534 is sponsored by St. Louis University. The principal investigator is David Greenberg, MD at St. Louis University. The trial plans to enroll 60 participants.