Post-Op Pain Control for Prophylactic Intramedullary Nailing.
St. Louis University
60 participants
Feb 20, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Femoral Shaft or Neck bone lesion
- years old or greater
- Plan to undergo prophylactic intramedullary nailing of one femur
Exclusion Criteria16
- 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
Interventions
IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details.
An IV normal saline placebo prepared by the hospital pharmacy.
acetaminophen 500 mg PO Q4 hours PRN for mild pain
oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
morphine IV PRN (or other opioid) for severe breakthrough pain
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03823534