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NCT Number: NCT03823534

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Ketorolac

Drug

IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details.

Other names: Toradol

normal saline

Drug

An IV normal saline placebo prepared by the hospital pharmacy.

Other names: Placebo

Acetaminophen

Drug

acetaminophen 500 mg PO Q4 hours PRN for mild pain

Other names: Tylenol

Oxycodone Acetaminophen

Drug

oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain

Other names: Percocet

Morphine

Drug

morphine IV PRN (or other opioid) for severe breakthrough pain

Hydrocodone/Acetaminophen

Drug

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.

Other names: Norco

Oxycodone

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale

    Time frame: Up to six weeks post-op

    Measure the effect of post-op ketorolac on PROMIS Pain Intensity score compared to the PROMIS of those that receive only opioids. Total scores are computed by summing the scores of the 3 individual questions. Possible scores range from 3-15 with higher values representing increasing pain over the previous 7 days.

  2. Single Assessment Numerical Evaluation (SANE)

    Time frame: Up to six weeks post-op

    Measure the effect of post-op ketorolac on SANE score compared to the SANE of those that receive only opioids. The score ranges from 0-100, with 100 representing the best possible perceived function of the limb and 0 the worst possible perceived function. There are no sub-scales.

  3. Numerical Rating Scale (NRS)

    Time frame: Up to six weeks post-op

    Measure the effect of post-op ketorolac on NRS score compared to the NRS of those that receive only opioids. Scores range from 0-10 with higher scores signifying increasing pain. There are no sub-scales.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Gruender, MSN

CONTACT

[email protected]

314-617-3406

David Greenberg, MD

CONTACT

[email protected]

314-617-3410

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jan 30, 2019
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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