Post-Op Pain Control for Prophylactic Intramedullary Nailing.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Louis University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Femoral Shaft or Neck bone lesion
18 years old or greater
Plan to undergo prophylactic intramedullary nailing of one femur
Disqualifiers
Concurrent pathologic fracture
History of advanced renal impairment (eGFR<30mL/min)
History of Peptic Ulcer Disease with bleeding or requiring hospitalization
History of NSAID or aspirin allergy
Trial design
Design model
Parallel
Treatments tested in this trial
Ketorolac
DrugIV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details.
Normal saline
DrugAn IV normal saline placebo prepared by the hospital pharmacy.
Acetaminophen
Drugacetaminophen 500 mg PO Q4 hours PRN for mild pain
Oxycodone Acetaminophen
Drugoxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
Morphine
Drugmorphine IV PRN (or other opioid) for severe breakthrough pain
Hydrocodone/Acetaminophen
DrugAt 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
DrugUpon 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Experimental ArmExperimental treatment 6 interventions
Group B: ControlPlacebo comparator 6 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Post-op days 1-14Secondary outcomes
1
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.
Time frame
Up to six weeks post-op2
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.
Time frame
Up to six weeks post-op3
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.
Time frame
Up to six weeks post-opSponsors and contacts
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Source ClinicalTrials.gov