Post-Op Pain Control for Prophylactic Intramedullary Nailing.

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

Interventions

DRUG

Ketorolac

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

DRUG

Normal saline

An IV normal saline placebo prepared by the hospital pharmacy.

DRUG

Acetaminophen

acetaminophen 500 mg PO Q4 hours PRN for mild pain

DRUG

Oxycodone Acetaminophen

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

DRUG

Morphine

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

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• St. Louis University

  lead OTHER

Principal Investigators

• David Greenberg, MD · St. Louis University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-20

Primary Completion

2026-12-31

Completion

2027-03-31

FDA Drug

Yes

Countries

• United States

Study Locations