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


Description

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.

Trial Eligibility

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.

Study Info

Organization

University of Miami


Primary Outcome

Rate of Opioid Use in Postoperative Period


Outcome Timeframe Up to 20 days

NCTID NCT05842044

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2023-09-15

Completion Date 2025-09-30

Enrollment Target 110

Interventions

DRUG Ketorolac

DRUG Acetaminophen

DRUG Oxycodone

DRUG Hydromorphone

DRUG Ibuprofen

Locations Recruiting

University of Miami

United States, Florida, Miami


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