RecruitingPhase 3NCT03823534

Post-Op Pain Control for Prophylactic Intramedullary Nailing.


Sponsor

St. Louis University

Enrollment

60 participants

Start Date

Feb 20, 2019

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing different methods of pain control after a surgery called prophylactic intramedullary nailing — a procedure where a metal rod is inserted inside a weakened thigh bone (femur) to prevent it from breaking, often done in cancer patients whose bones are weakened by the disease. **You may be eligible if...** - You are 18 years or older - You have a bone lesion (a weakened or abnormal area) in your thigh bone (femur shaft or neck) - You are scheduled to have prophylactic intramedullary nailing of one femur (the rod-insertion surgery) **You may NOT be eligible if...** - You already have a broken bone at the site of surgery - You have severe kidney disease (eGFR below 30) - You have a history of peptic ulcers with bleeding or requiring hospitalization - You have an allergy to NSAIDs (like ibuprofen) or aspirin - Your chemotherapy regimen prevents NSAID use - You have liver disease, heart failure, or cardiovascular disease that prevents use of certain pain medications - You are pregnant, or have a bleeding disorder or are on blood thinners Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetorolac

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

DRUGNormal saline

An IV normal saline placebo prepared by the hospital pharmacy.

DRUGAcetaminophen

acetaminophen 500 mg PO Q4 hours PRN for mild pain

DRUGOxycodone Acetaminophen

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

DRUGMorphine

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

DRUGHydrocodone/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.

DRUGOxycodone

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)

Saint Louis University

St Louis, Missouri, United States

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NCT03823534


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