Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Pain Clinical Trial

Official title:

Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03823534
• Other study ID #: 28927
• Status: Recruiting
• Phase: Phase 3
• Start date: February 20, 2019
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2023
• Source: St. Louis University
• Contact: David Greenberg, MD
• Phone: 314-617-3410
• Email: david.greenberg[@]health.slu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Femoral Shaft or Neck bone lesion

2. 18 years old or greater

3. Plan to undergo prophylactic intramedullary nailing of one femur

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bone Metastases
• Lymphoma
• Multiple Myeloma
• Neoplasm Metastasis
• Opioid Use
• Pain
• Pain, Postoperative

Intervention

Drug:
• Ketorolac
IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details.
• Normal saline
An IV normal saline placebo prepared by the hospital pharmacy.
• Acetaminophen
acetaminophen 500 mg PO Q4 hours PRN for mild pain
• Oxycodone Acetaminophen
oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
• Morphine
morphine IV PRN (or other opioid) for severe breakthrough pain
• 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.
• 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.

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale	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.	Up to six weeks post-op
Secondary	Single Assessment Numerical Evaluation (SANE)	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.	Up to six weeks post-op
Secondary	Numerical Rating Scale (NRS)	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.	Up to six weeks post-op