Post-Op Pain Control for Prophylactic Intramedullary Nailing.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketorolac, Normal saline, Acetaminophen, Oxycodone Acetaminophen.
- Who it may be relevant to
- Registry conditions: Bone Metastases, Lymphoma, Multiple Myeloma, Opioid Use. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Drug Ketorolac
IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details. - Drug Normal saline
An IV normal saline placebo prepared by the hospital pharmacy. - Drug Acetaminophen
acetaminophen 500 mg PO Q4 hours PRN for mild pain - Drug Oxycodone Acetaminophen
oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain - 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. - 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.
Primary outcome measures
- Milligram Morphine Equivalent (MME) of Opioid Medications Utilized [Time frame: Post-op days 1-14]
Secondary outcome measures (3)
- Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale [Time frame: Up to six weeks post-op]
- Single Assessment Numerical Evaluation (SANE) [Time frame: Up to six weeks post-op]
- Numerical Rating Scale (NRS) [Time frame: Up to six weeks post-op]
Eligibility criteria
Inclusion criteria
- Femoral Shaft or Neck bone lesion
- 18 years old or greater
- Plan to undergo prophylactic intramedullary nailing of one femur
Exclusion criteria
- 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
- Concurrent chemotherapy regimen that prevents NSAID use
- History of liver disease that precludes use of toradol
- History of heart failure or cardiovascular disease that precludes toradol usage
- Pregnancy
- History of narcotic allergy resulting in anaphylaxis
- 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 resulting in anaphylaxis
- Current use of the medication probenecid
- Current use of the medication Pentoxifylline
- History of aspirin induced asthma.
- Known history of opioid dependence, abuse, or addiction.
- Bilateral IMN of the femurs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Saint Louis University — St Louis
Publications
- 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. PMID 16306736
Identifiers
NCT: NCT03823534 · 28927