Saint Louis University
St Louis, Missouri, 63110, United States
Location status: Recruiting
NCT Number: NCT03823534
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
St Louis, Missouri, 63110, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
An IV normal saline placebo prepared by the hospital pharmacy.
Other names: Placebo
acetaminophen 500 mg PO Q4 hours PRN for mild pain
Other names: Tylenol
oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
Other names: Percocet
morphine IV PRN (or other opioid) for severe breakthrough pain
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
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Allison Gruender, MSN
CONTACT
David Greenberg, MD
CONTACT
St. Louis University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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