NCT05842044 · University of Miami
NSAID Use After Robotic Partial Nephrectomy
(No-PAIN)
What this study is about
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.
View original scientific 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.
Interventions
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.
Primary outcome measures
Rate of Opioid Use in Postoperative Period
Time frame: Up to 20 days
Rate of opioid use is defined as the number of participants who used opioid medications during the post-operative period (defined as end of surgery to post-operative follow up visit) divided by total number of participants in the group at postoperative visit.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
- 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.
- Inability to give informed consent or unable to meet requirement of the study for any reason.
Where
- Miami, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 5, 2025 · Source of record for eligibility and locations