Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03823534
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
David Greenberg, MD;; Assistant Professor, St. Louis University

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.

Condition or disease Intervention/treatment Phase
Bone Metastases Lymphoma Multiple Myeloma Opioid Use Pain Drug: Ketorolac Drug: Normal saline Drug: Acetaminophen Drug: Oxycodone Acetaminophen Drug: Morphine Drug: Hydrocodone/Acetaminophen Drug: Oxycodone Phase 3

Detailed 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, often due to bone metastases that increase risk for future fractures. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use.

Recent literature has demonstrated the efficacy of multi-modal pain management in treating post-op pain [1]. Currently, patients that undergo prophylactic intramedullary femur nail placement at SLU are often treated with both narcotics and toradol, as long as they can tolerate NSAIDs. However, the effect of toradol in addition to narcotics has not been determined. 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a prospective, randomized, double-blind, placebo-controlled trial.
Masking: Double (Participant, Investigator)
Masking Description: Both the patient and study investigators will be blinded. The hospital pharmacy will be unblinded.
Primary Purpose: Treatment
Official Title: Post-Op Pain Control for Prophylactic Intramedullary Nailing.
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Ketorolac
IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details.
Other Name: Toradol

Drug: Acetaminophen
acetaminophen 500 mg PO Q4 hours PRN for mild pain
Other Name: Tylenol

Drug: Oxycodone Acetaminophen
oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
Other Name: Percocet

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.
Other Name: Norco

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.

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.
Drug: Normal saline
An IV normal saline placebo prepared by the hospital pharmacy.
Other Name: Placebo

Drug: Acetaminophen
acetaminophen 500 mg PO Q4 hours PRN for mild pain
Other Name: Tylenol

Drug: Oxycodone Acetaminophen
oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
Other Name: Percocet

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.
Other Name: Norco

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.




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


Secondary Outcome Measures :
  1. Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale [ Time Frame: Up to six weeks post-op ]
    Measure the effect of post-op ketorolac on PROMIS Pain Intensity score compared to the PROMIS of those that receive only opioids. Total scores are computed by summing the scores of the 3 individual questions. Possible scores range from 3-15 with higher values representing increasing pain over the previous 7 days.

  2. Single Assessment Numerical Evaluation (SANE) [ Time Frame: Up to six weeks post-op ]
    Measure the effect of post-op ketorolac on SANE score compared to the SANE of those that receive only opioids. The score ranges from 0-100, with 100 representing the best possible perceived function of the limb and 0 the worst possible perceived function. There are no sub-scales.

  3. Numerical Rating Scale (NRS) [ Time Frame: Up to six weeks post-op ]
    Measure the effect of post-op ketorolac on NRS score compared to the NRS of those that receive only opioids. Scores range from 0-10 with higher scores signifying increasing pain. There are no sub-scales.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Concurrent pathologic fracture
  2. History of advanced renal impairment
  3. History of Peptic Ulcer Disease
  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
  8. Pregnancy
  9. History of opioid allergy that prevents used of opioids
  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.
  12. Current use of the medication probenecid
  13. Current use of the medication Pentoxifylline
  14. History of aspirin induced asthma.
  15. History of coronary artery bypass graft
  16. Known history of opioid dependence, abuse, or addiction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823534


Contacts
Layout table for location contacts
Contact: David Greenberg, MD 3145778904 david.greenberg@health.slu.edu
Contact: Sarah Dawson, BSN sarah.dawson@health.slu.edu

Locations
Layout table for location information
United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Sarah A Dawson, BSN    314-577-8527    sarah.dawson@slu.edu   
Sponsors and Collaborators
St. Louis University
Investigators
Layout table for investigator information
Principal Investigator: David Greenberg, MD St. Louis University

Publications:
Layout table for additonal information
Responsible Party: David Greenberg, MD;; Assistant Professor, Associate Professor, Orthopaedic Surgery, St. Louis University
ClinicalTrials.gov Identifier: NCT03823534     History of Changes
Other Study ID Numbers: 28927
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by David Greenberg, MD;; Assistant Professor, St. Louis University:
Toradol
Ketorolac
Prophylactic intramedullary nail
bone metastases
Opioid use
post-operative pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasm Metastasis
Pain, Postoperative
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Morphine
Oxycodone
Hydrocodone
Acetaminophen, hydrocodone drug combination
Acetaminophen
Ketorolac
Ketorolac Tromethamine