Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-20

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bone Metastases Lymphoma Multiple Myeloma Opioid Use Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Both the patient and study investigators will be blinded. The hospital pharmacy will be unblinded.

Study Groups

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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.

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

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

Acetaminophen

Intervention Type DRUG

acetaminophen 500 mg PO Q4 hours PRN for mild pain

Oxycodone Acetaminophen

Intervention Type DRUG

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

Morphine

Intervention Type DRUG

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

Hydrocodone/Acetaminophen

Intervention Type 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.

Oxycodone

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

An IV normal saline placebo prepared by the hospital pharmacy.

Acetaminophen

Intervention Type DRUG

acetaminophen 500 mg PO Q4 hours PRN for mild pain

Oxycodone Acetaminophen

Intervention Type DRUG

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

Morphine

Intervention Type DRUG

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

Hydrocodone/Acetaminophen

Intervention Type 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.

Oxycodone

Intervention Type 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.

Interventions

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Ketorolac

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

Intervention Type DRUG

Normal saline

An IV normal saline placebo prepared by the hospital pharmacy.

Intervention Type DRUG

Acetaminophen

acetaminophen 500 mg PO Q4 hours PRN for mild pain

Intervention Type DRUG

Oxycodone Acetaminophen

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

Intervention Type DRUG

Morphine

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Toradol Placebo Tylenol Percocet Norco

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No