Multiple Myeloma Clinical Trial

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Femoral Shaft or Neck bone lesion
18 years old or greater
Plan to undergo prophylactic intramedullary nailing of one or both femurs

Exclusion Criteria:

Concurrent pathologic fracture
History of advanced renal impairment
History of Peptic Ulcer Disease
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
Pregnancy
History of opioid allergy that prevents used of opioids
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.
Current use of the medication probenecid
Current use of the medication Pentoxifylline
History of aspirin induced asthma.
History of coronary artery bypass graft
Known history of opioid dependence, abuse, or addiction.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

60

Study ID:

NCT03823534

Recruitment Status:

Recruiting

Sponsor:

St. Louis University

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There is 1 Location for this study

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Saint Louis University
Saint Louis Missouri, 63110, United States More Info
Allison Gruender, MSN
Contact
314-977-4106
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

60

Study ID:

NCT03823534

Recruitment Status:

Recruiting

Sponsor:


St. Louis University

How clear is this clinincal trial information?

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