RECRUITING

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Conditions

Bone Metastases Lymphoma Multiple Myeloma Opioid Use Pain Toradol Ketorolac Prophylactic intramedullary nail post-operative pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Quick Facts

Study Start:2019-02-20

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03823534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Femoral Shaft or Neck bone lesion 2. 18 years old or greater 3. Plan to undergo prophylactic intramedullary nailing of one femur	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

Inclusion Criteria

Exclusion Criteria

1. Femoral Shaft or Neck bone lesion
2. 18 years old or greater
3. Plan to undergo prophylactic intramedullary nailing of one femur

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

Contacts and Locations

Study Contact

David Greenberg, MD

CONTACT

314-617-3410

david.greenberg@health.slu.edu

Allison Gruender, MSN

CONTACT

314-617-3406

allison.gruender@health.slu.edu

Principal Investigator

David Greenberg, MD

PRINCIPAL_INVESTIGATOR

St. Louis University

Study Locations (Sites)

Saint Louis University

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: St. Louis University

David Greenberg, MD, PRINCIPAL_INVESTIGATOR, St. Louis University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-20

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2019-02-20

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Bone Metastases
Lymphoma
Multiple Myeloma
Opioid Use
Pain