Recruiting
Phase 3

Prophylactic Nailing

Sponsor:

St. Louis University

Code:

NCT03823534

Conditions

Bone Metastases

Lymphoma

Multiple Myeloma

Opioid Use

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketorolac

Normal saline

Acetaminophen

Oxycodone Acetaminophen

Morphine

Study Details

Brief 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.

Conditions

Bone Metastases

Lymphoma

Multiple Myeloma

Opioid Use

Pain

Study ID

NCT03823534

Start date

Feb 20, 2019

Status verified date

Apr, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm

For the first 24 hours following surgery, patients younger than 65 years old will be administered a maximum of 120 mg/day bolus IV ketorolac (30 mg every 6 hours). Patients older than 65 years old or with history of advanced renal impairment will receive a maximum of 60 mg/day bolus IV ketorolac (15 mg every 6 hours). All patients may also be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate- severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. At discharge, they will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours, quantity 50. Those with preexisting liver disease will be prescribed the equivalent in oxycodone and will not receive acetaminophen for mild pain.

placebo comparator: Control

Following surgery, patients will be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate-severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. They will also be given a placebo injection of normal saline every 6 hours for the first 24 hours following surgery. At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours PRN quantity 50, unless they have preexisting liver disease, in which case they will be prescribed the equivalent in oxycodone. They will not receive a nerve block.

Interventions

Ketorolac

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

Normal saline

An IV normal saline placebo prepared by the hospital pharmacy.

Acetaminophen

acetaminophen 500 mg PO Q4 hours PRN for mild pain

Oxycodone Acetaminophen

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

Morphine

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

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.

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 measure

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

Central Contacts and Locations

Central contacts

David Greenberg, MD

314-617-3410david.greenberg@health.slu.edu

Allison Gruender, MSN

314-617-3406allison.gruender@health.slu.edu

Locations

Saint Louis University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Allison Gruender, MSN

314-617-3406allison.gruender@health.slu.edu

More Information

Sponsor

St. Louis University

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Toradol
  • Ketorolac
  • Prophylactic intramedullary nail
  • bone metastases
  • Opioid use
  • post-operative pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Louis University on 2026-04-22.