NCT03823534 · St. Louis University
Post-Op Pain Control for Prophylactic Intramedullary Nailing.
What this study is about
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.
View original scientific 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. 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.
Interventions
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.
Primary outcome measures
Milligram Morphine Equivalent (MME) of Opioid Medications Utilized
Time frame: Post-op days 1-14
Measure the effect of post-op ketorolac on the concurrent use of opioid pain medications during post-op days 1-14 following prophylactic IMN of the femur compared to patients treated only with opioids.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Femoral Shaft or Neck bone lesion
- 18 years old or greater
- Plan to undergo prophylactic intramedullary nailing of one femur
Exclusion criteria
- 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
- 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
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations