Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Обзор

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.

Подробное 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.

Вмешательства

• Препарат Ketorolac
  IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details.
• Препарат Normal saline
  An IV normal saline placebo prepared by the hospital pharmacy.
• Препарат Acetaminophen
  acetaminophen 500 mg PO Q4 hours PRN for mild pain
• Препарат Oxycodone Acetaminophen
  oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
• Препарат Morphine
  morphine IV PRN (or other opioid) for severe breakthrough pain
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Milligram Morphine Equivalent (MME) of Opioid Medications Utilized [Срок оценки: Post-op days 1-14]

Вторичные конечные точки (3)

• Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale [Срок оценки: Up to six weeks post-op]
• Single Assessment Numerical Evaluation (SANE) [Срок оценки: Up to six weeks post-op]
• Numerical Rating Scale (NRS) [Срок оценки: Up to six weeks post-op]

Критерии участия

Критерии включения

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

Критерии исключения

• Concurrent pathologic fracture
• History of advanced renal impairment (eGFR<30mL/min)
• History of Peptic Ulcer Disease with bleeding or requiring hospitalization
• 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 that precludes toradol usage
• Pregnancy
• History of narcotic allergy resulting in anaphylaxis
• 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 resulting in anaphylaxis
• Current use of the medication probenecid
• Current use of the medication Pentoxifylline
• History of aspirin induced asthma.
• Known history of opioid dependence, abuse, or addiction.
• Bilateral IMN of the femurs

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Saint Louis University — St Louis

Публикации

• Cepeda MS, Carr DB, Miranda N, Diaz A, Silva C, Morales O. Comparison of morphine, ketorolac, and their combination for postoperative pain: results from a large, randomized, double-blind trial. Anesthesiology. 2005 Dec;103(6):1225-32. doi: 10.1097/00000542-200512000-00018. PMID 16306736

Идентификаторы

NCT: NCT03823534 · 28927

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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