Език: EN EN
← Назад към резултатите
Набира участници Фаза 3 NCT03823534

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Фаза 3 – широко изпитване преди одобрение
Заболявания: Bone Metastases Lymphoma Multiple Myeloma Opioid Use Pain

Спонсор: St. Louis University

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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
Интервенции
Ketorolac
DRUG
Normal saline
DRUG
Acetaminophen
DRUG
Oxycodone Acetaminophen
DRUG
Morphine
DRUG
Hydrocodone/Acetaminophen
DRUG
Oxycodone
DRUG
Места на провеждане 1
САЩ (1)
Saint Louis University
St Louis , Missouri
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
20.02.2019
Крайна дата
31.03.2027
Регистрационен номер
NCT03823534
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.