NCT03823534

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: St. Louis University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Bone Metastases
• Lymphoma
• Multiple Myeloma
• Opioid Use
• Pain

Interventions

Type	Name	Description
DRUG	Ketorolac	IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details.
DRUG	Normal saline	An IV normal saline placebo prepared by the hospital pharmacy.
DRUG	Acetaminophen	acetaminophen 500 mg PO Q4 hours PRN for mild pain
DRUG	Oxycodone Acetaminophen	oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
DRUG	Morphine	morphine IV PRN (or other opioid) for severe breakthrough pain
DRUG	Hydrocodone/Acetaminophen	At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours. Those with preexisting liver disease will be prescribed the equivalent in oxycodone.
DRUG	Oxycodone	Upon discharge, patients will be prescribed the equivalent of 1-2 hydrocodone 5mg Q4 hours upon should they have preexisting liver disease and are unable to consume acetaminophen.

Timeline

• Start date: 2019-02-20
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2019-01-30
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study