Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Sponsor

St. Louis University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03823534

Collaborator

(none)

Enrollment

Location

Arms

67.4

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Feb 20, 2019

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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 Names: Toradol Drug: Acetaminophen acetaminophen 500 mg PO Q4 hours PRN for mild pain Other Names: Tylenol Drug: Oxycodone Acetaminophen oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain Other Names: 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 Names: 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 Names: Placebo Drug: Acetaminophen acetaminophen 500 mg PO Q4 hours PRN for mild pain Other Names: Tylenol Drug: Oxycodone Acetaminophen oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain Other Names: 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 Names: 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.

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 Names:

Toradol

Drug: Acetaminophen

acetaminophen 500 mg PO Q4 hours PRN for mild pain

Other Names:

Tylenol

Drug: Oxycodone Acetaminophen

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

Other Names:

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 Names:

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 Names:

Placebo

Drug: Acetaminophen

acetaminophen 500 mg PO Q4 hours PRN for mild pain

Other Names:

Tylenol

Drug: Oxycodone Acetaminophen

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

Other Names:

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Milligram Morphine Equivalent (MME) of Opioid Medications Utilized [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

Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale [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.
Single Assessment Numerical Evaluation (SANE) [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.
Numerical Rating Scale (NRS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Concurrent pathologic fracture
History of advanced renal impairment
History of Peptic Ulcer Disease
History of NSAID or aspirin allergy
Concurrent chemotherapy regimen that prevents NSAID use
History of liver disease that precludes use of toradol
History of heart failure or cardiovascular disease
Pregnancy
History of opioid allergy that prevents used of opioids
Patients with coagulation disorders or those who require concomitant use of anticoagulant or anti- platelet therapy during the treatment phase of the study.
Patients with acetaminophen allergies.
Current use of the medication probenecid
Current use of the medication Pentoxifylline
History of aspirin induced asthma.
History of coronary artery bypass graft
Known history of opioid dependence, abuse, or addiction.