Post-Op Pain Control for Prophylactic Intramedullary Nailing.

NCT03823534 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 28927
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Milligram Morphine Equivalent (MME) of Opioid Medications Utilized

  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.

  Post-op days 1-14

Secondary Outcomes (3)

• Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale

  Up to six weeks post-op

• Single Assessment Numerical Evaluation (SANE)

  Up to six weeks post-op

• Numerical Rating Scale (NRS)

  Up to six weeks post-op

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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.

Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone Acetaminophen; Drug: Morphine; Drug: Hydrocodone/Acetaminophen; Drug: Oxycodone

Control

PLACEBO COMPARATOR

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.

Drug: Normal saline; Drug: Acetaminophen; Drug: Oxycodone Acetaminophen; Drug: Morphine; Drug: Hydrocodone/Acetaminophen; Drug: Oxycodone

Interventions

Ketorolac DRUG

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

Also known as: Toradol

Experimental Arm

Normal saline DRUG

An IV normal saline placebo prepared by the hospital pharmacy.

Also known as: Placebo

Control

Acetaminophen DRUG

acetaminophen 500 mg PO Q4 hours PRN for mild pain

Also known as: Tylenol

Control; Experimental Arm

Oxycodone Acetaminophen DRUG

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

Also known as: Percocet

Control; Experimental Arm

Morphine DRUG

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

Control; Experimental Arm

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.

Also known as: Norco

Control; Experimental Arm

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.

Control; Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Femoral Shaft or Neck bone lesion
• years old or greater
• Plan to undergo prophylactic intramedullary nailing of one femur

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (1)

• Cepeda MS, Carr DB, Miranda N, Diaz A, Silva C, Morales O. Comparison of morphine, ketorolac, and their combination for postoperative pain: results from a large, randomized, double-blind trial. Anesthesiology. 2005 Dec;103(6):1225-32. doi: 10.1097/00000542-200512000-00018.

  PMID: 16306736 BACKGROUND

MeSH Terms

Conditions

Lymphoma; Multiple Myeloma; Pain; Pain, Postoperative

Interventions

Ketorolac; Ketorolac Tromethamine; Saline Solution; Acetaminophen; oxycodone-acetaminophen; Morphine; Oxycodone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Study Officials

• David Greenberg, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Greenberg, MD

CONTACT

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

Allison Gruender, MSN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the patient and study investigators will be blinded. The hospital pharmacy will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Orthopaedic Surgery

Model Details: This study is a prospective, randomized, double-blind, placebo-controlled trial.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 30, 2019
• Study Start: February 20, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)