Study Results
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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RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2023-09-15
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: NSAID
Participants in this group will be prescribed NSAIDs instead of the standard of care treatment. Participants will be in this group for approximately 21 days.
Ketorolac
15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.
Acetaminophen
1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
Oxycodone
Standardized regimen of Oxycodone administered orally (PO) on demand for moderate pain during post-surgery (inpatient) period.
At discharge 5mg Oxycodone will be administered to participants on demand if pain score is greater than 7, or if participant required greater than 25mg Oxycodone during the hospitalization.
Hydromorphone
Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
Ibuprofen
400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.
Group 2: No-NSAID
Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.
Acetaminophen
1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
Oxycodone
Standardized regimen of Oxycodone administered orally (PO) on demand for moderate pain during post-surgery (inpatient) period.
At discharge 5mg Oxycodone will be administered to participants on demand if pain score is greater than 7, or if participant required greater than 25mg Oxycodone during the hospitalization.
Hydromorphone
Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
Interventions
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Ketorolac
15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.
Acetaminophen
1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
Oxycodone
Standardized regimen of Oxycodone administered orally (PO) on demand for moderate pain during post-surgery (inpatient) period.
At discharge 5mg Oxycodone will be administered to participants on demand if pain score is greater than 7, or if participant required greater than 25mg Oxycodone during the hospitalization.
Hydromorphone
Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
Ibuprofen
400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-99.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* Myocardial infarction or unstable angina within 12 months.
* Any history of coronary artery bypass graft surgery.
* History or active peptic ulcer disease, gastrointestinal (GI) bleeding, GI perforation. History of bleeding disorder. Glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) equation).
* Taking any anti-platelet or anti-coagulation medications concurrently (e.g. warfarin, aspirin, clopidogrel, rivaroxaban etc.)
* Chronic opioid use (use within 12 weeks) or history of opioid use disorder.
* Solitary kidney.
* Pregnancy.
* Inability to give informed consent or unable to meet requirement of the study for any reason.
18 Years
99 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Mark L. Gonzalgo, MD, PhD
Professor of Clinical
Principal Investigators
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Mark L Gonzalgo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20220783
Identifier Type: -
Identifier Source: org_study_id
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