NSAID Use After Robotic Partial Nephrectomy
NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial
University of Miami
110 participants
Sep 15, 2023
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to see how effective non-steroidal anti-inflammatory drugs (NSAIDs) are at controlling pain without side effects in participants after robotic-assisted partial nephrectomy.
Eligibility
Inclusion Criteria3
- Patients undergoing uncomplicated robotic assisted laparoscopic partial nephrectomy for renal mass at the University of Miami Hospital and Network Sites (Deerfield Beach, Plantation, Lennar (Coral Gables), and Kendal).
- Age 18-99.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria9
- Allergy to NSAIDs
- 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.
Interventions
15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.
1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
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.
Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05842044