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RECRUITINGPhase 2INTERVENTIONAL

NSAID Use After Robotic Partial Nephrectomy

NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form document. Who Should NOT Join This Trial: - 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 willing to sign a consent form or unable to meet requirement of the study for any reason. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * 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.

Treatments Being Tested

DRUG

Ketorolac

15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.

DRUG

Acetaminophen

1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.

DRUG

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.

DRUG

Hydromorphone

Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.

DRUG

Ibuprofen

400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.

Locations (1)

University of Miami
Miami, Florida, United States