Post-Op Pain Control for Prophylactic Intramedullary Nailing.

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Louis University
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Analgesics, Opioid; Hydrocodone; Ketorolac; Ketorolac Tromethamine; Morphine; Oxycodone

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 or both femurs

Exclusion Criteria:

1. Concurrent pathologic fracture

2. History of advanced renal impairment

3. History of Peptic Ulcer Disease

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

8. Pregnancy

9. History of opioid allergy that prevents used of opioids

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.

12. Current use of the medication probenecid

13. Current use of the medication Pentoxifylline

14. History of aspirin induced asthma.

15. History of coronary artery bypass graft

16. Known history of opioid dependence, abuse, or addiction.