RecruitingPhase 2NCT05842044

NSAID Use After Robotic Partial Nephrectomy

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


Sponsor

University of Miami

Enrollment

110 participants

Start Date

Sep 15, 2023

Study Type

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether anti-inflammatory pain medications called NSAIDs (such as ibuprofen) can safely reduce pain and reduce the need for opioids after minimally invasive (robotic) kidney surgery to remove a small kidney tumor. It aims to find a safer pain management strategy after this increasingly common procedure. **You may be eligible if...** - You are 18 to 99 years old - You are having robotic-assisted partial nephrectomy (removal of part of the kidney) for a kidney mass - The surgery is uncomplicated and straightforward **You may NOT be eligible if...** - You are allergic to NSAIDs (like ibuprofen or naproxen) - You have had a recent heart attack or unstable angina within the past year - You have a history of heart bypass surgery, peptic ulcers, or gastrointestinal bleeding - You have significant kidney or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetorolac

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

DRUGAcetaminophen

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

DRUGOxycodone

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.

DRUGHydromorphone

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

DRUGIbuprofen

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


Locations(1)

University of Miami

Miami, Florida, United States

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NCT05842044


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